Product code LOX— Cardiovascular

Death

190

Injury

1,498

Malfunction

9,670

Total

11,358

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• K252116 — Firefighter™ Pro PTCA Balloon CatheterShanghai MicroPort Medical (Group) Co., Ltd.·2026-04-07
• K254022 — FLASH Flex™ Aorto-Ostial Angioplasty SystemVerge Medical, Inc.·2026-04-02
• K252295 — RyureiTerumo Corporation·2026-03-27
• K251970 — Sprinter Legend Rapid Exchange Balloon Dilatation CatheterMedtronic, Ireland·2026-01-17
• K242969 — Pantera Pro; Pantera LEOBiotronik, Inc.·2024-10-25
• K233499 — Sapphire NC ULTRA Coronary Dilatation CatheterOrbusNeich Medical (Shenzhen) Co., Ltd.·2024-08-16
• K233505 — Sapphire ULTRA Coronary Dilatation CatheterOrbusNeich Medical (Shenzhen) Co., Ltd.·2024-08-15
• K233729 — Ringer perfusion balloon catheter, 2.00 x 20mm (5881); Ringer perfusion balloon catheter, 2.50 x 20mm (5882); Ringer perfusion balloon catheter, 2.50 x 30mm (5883); Ringer perfusion balloon catheter, 3.00 x 20mm (5884); Ringer perfusion balloon catheter, 3.00 x 30mm (5885); Ringer perfusion balloon catheter, 3.50 x 20mm (5886); Ringer perfusion balloon catheter, 3.50 x 30mm (5887); Ringer perfusion balloon catheter, 4.00 x 20mm (5888); Ringer perfusion balloon catheter, 4.00 x 30mm (58Vascular Solutions, LLC·2024-05-31
• K223189 — Firefighter™ NC Pro PTCA Balloon CatheterShanghai MicroPort Medical (Group) Co., Ltd.·2023-07-21
• K230374 — Coronary Dilatation Balloon Catheter (VesPenetrator®), Coronary Dilatation Balloon Catheter (VesTraveler®), Coronary Dilatation Balloon Catheter (VexPander®)Dongguan TT Medical, Inc.·2023-06-29
• K230705 — POT PTCA Balloon Dilatation CatheterBrosmed Medical Co., Ltd.·2023-04-11
• K223022 — SC HONKYTONK PTCA Balloon Dilatation CatheterSino Medical Sciences Technology, Inc.·2023-02-15
• K222538 — NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation CatheterSino Medical Sciences Technology, Inc.·2022-12-21
• K220634 — NC TREK NEO Coronary Dilatation CatheterAbbott Vascular·2022-06-30
• K220629 — Emerge Monorail PTCA Dilatation CatheterBoston Scientific·2022-03-24
• K212393 — OPN NC PTCA Dilatation CatheterSis Medical AG·2022-03-14
• K211349 — Selebrek PTCA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.·2022-01-07
• K211807 — Sapphire NC 24OrbusNeich Medical (Shenzhen) Co., Ltd.·2021-10-14
• K210012 — Tamarin Blue PTCA RX Dilatation CatheterNatec Medical , Ltd.·2021-07-09
• K211393 — Selethru(TM) NC PTCA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.·2021-07-02
• K202578 — KardiFlex NC Coronary Dilatation CatheterMedcaptain Life Science Co., Ltd.·2021-05-06
• K202619 — KardiFlex PTCA Balloon Dilatation CatheterMedcaptain Life Science Co., Ltd.·2021-04-29
• K203390 — Artimes pro Balloon Dilatation CatheterBrosmed Medical Co., Ltd.·2021-04-14
• K200269 — Sapphire II PROOrbusneich Medical Trading, Inc.·2020-03-04
• K192344 — Sapphire NC Plus Coronary Dilatation CatheterOrbusneich Medical Trading, Inc.·2019-09-19
• K182699 — Selethru PTCA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.·2018-11-26
• K180040 — NC TREK™ RX Coronary Dilatation Catheter; NC TREK™ OTW Coronary Dilatation Catheter; TREK™ RX Coronary Dilatation Catheter; TREK™ OTW Coronary Dilatation Catheter; MINI TREK™ RX Coronary Dilatation Catheter; MINI TREK™ OTW Coronary Dilatation Catheter; MINI TREK™ II OTW Coronary Dilatation CatheterAbbott Vascular·2018-08-24
• K180921 — Sapphire II PRO Balloon Dilatation CatheterOrbusneich Medical Trading, Inc.·2018-06-28
• K181023 — Mozec – Rx PTCA Balloon Dilatation Catheter, Mozec NC – Rx PTCA Balloon Dilatation CatheterMeril Life Sciences Private Limited·2018-05-17
• K172264 — OTW Takeru PTCA Balloon Dilatation CatheterKANEKA Corporation·2018-03-19
• K173680 — Sapphire II PROOrbusneich Medical Trading, Inc.·2018-03-01
• K173581 — Gallant PTCA Dilatation CatheterMedinol, Ltd.·2018-01-25
• K170941 — RX NC Takeru PTCA Balloon Dilatation CatheterKANEKA Corporation·2017-07-07
• K162625 — SeQuent Neo Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon CathetersB. Braun Interventional Systems, Inc.·2017-06-12
• K163372 — RX Takeru Balloon Dilatation CatheterKANEKA Corporation·2017-04-07
• K163660 — Pantera LEOBiotronik, Inc.·2017-01-26
• K162434 — NC Gallant PTCA CatheterMedinol, Ltd.·2017-01-19
• K163114 — Sapphire II PROOrbusneich Medical, Inc.·2017-01-05
• K163174 — Emerge PTCA Dilatation CatheterBoston Scientific Corporation·2016-12-14
• K163200 — Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation CatheteBoston Scientific Corporation·2016-12-14
• K160985 — Pantera ProBiotronik, Inc.·2016-10-07
• K162209 — Sapphire NC PlusOrbusneich Medical, Inc.·2016-10-06
• K153742 — Apollo Balloon Dilatation CatheterBrosmed Medical Co., Ltd.·2016-08-08
• K160961 — Mozec NC-Rx PTCA Baloon Dilatation CatheterMeril Life Sciences Private Limited·2016-07-30
• K153682 — Chocolate XD PTCA Balloon CatheterTrireme Medical, LLC·2016-06-23
• K160823 — NC Quantum Apex PTCA Dilatation CatheterBoston Scientific Corporation·2016-06-23
• K152485 — FLASH Mini Ostial System - 3.0mm x 8mm x 135cm, FLASH Mini Ostial System - 3.5mm x 8mm x 135cm, FLASH Mini Ostial System - 4.0mm x 8mm x 135cm, FLASH Mini Ostial System - 4.5mm x 8mm x 135cmOstial Corporation·2016-02-16
• K141933 — FILAO NC RX PTCA DILATATION CATHETERNatec Medical , Ltd.·2015-06-28
• K150292 — Chocolate PTCA Balloon CatheterTrireme Medical, LLC·2015-04-09
• K143480 — Euphora Rapid Exchange Balloon Dilatation CatheterMedtronic, Inc.·2015-04-02
• K143160 — FOXTROT NC PTCA Balloon CatheterShanghai MicroPort Medical (Group) Co., Ltd.·2015-03-05
• K133852 — APOLLO BALLOON DILATATION CATHETERBrosmed Medical·2014-09-19
• K141025 — ARTIMES BALLOON DILATATION CATHETERBrosmed Medical·2014-09-12
• K141090 — NC EUPHORA RAPID EXCHANGE BALLOON DILATATION CATHETERMedtronic, Inc.·2014-08-15
• K141236 — NC EMERGE PTCA DILATATION CATHETER (MONORAIL), NC EMERGE PTCA DILATATION CATHETER (OVER-THE-WIRE)Boston Scientific Corporation·2014-08-07
• K134031 — THREADER MONORAIL MICRO-DILATATION CATHETER, THREADER OVER-THE-WIRE MICRO-DILATATION CATHETERBoston Scientific Corporation·2014-07-21
• K133633 — CHOCOLATE PTCA BOLLOON CATHETERTrireme Medical, Inc.·2014-06-02
• K131169 — MOZEC - RX PTCA BALLOON DILATATION CATHETERMeril Life Sciences Private Limited·2013-12-24
• K123473 — HOPER PTCA BALLOON CATHETERLepu Medical Technology (Beijing) Co., Ltd.·2013-08-13
• K131450 — FLASH MINI OSTIAL SYSTEM - 3.0MM X 135CM, FLASH MINI OSTIAL SYSTEM - 3.5MM X 8MM X 135CM, FLASH MINI OSTIAL SYSTEM - 4.0Ostial Corporation·2013-08-06
• K130391 — EMERGE MONORAIL PTCA DILATATION CATHETER, EMERGE PUSH MONORAIL PTCA DILATATION CATHETER, EMERGE OVER-THE-WIRE PTCA DILATBoston Scientific Corp·2013-07-10
• K123279 — MINI TREK RX CORONARY DILATATION CATHETER (INCLUDING 1.20 MM SIZE), MINI TREK OTW CORONARY DILATATION CATHETER (INCLUDINAbbott Vascular·2013-01-30
• K123264 — DK-PTCA BALLOON CATHETERIntuit Medical, LLC·2013-01-16
• K112735 — TAMARIN BLUE PTCA RX DILATATION CATHETERNatec Medical , Ltd.·2012-11-02
• K122178 — FLASH-C PTCA BALLOON DILATATION CATHETER - 4MM X 14MM X 135CM, FLASH-C PTCA BALLOON DILATATION CATHETER - 4MM X 19MM X 1Ostial Corporation·2012-10-11
• K121196 — EMERGE PTCA DILATATION CATHETER (MONORAIL) EMERGE PTCA DILATATION CATHETER (OVER-THE-WIRE)Boston Scientific Corp·2012-08-31
• K121667 — NC QUANTUM APEX PTCA DILATATION CATHETER (MONORAIL)Boston Scientific Corp·2012-08-13
• K113775 — FLASH-C PTCA BALLOON DILATATION CATHETER- 4.0MM X 14MM X 135CM -4.0MM X 19MM X 135CM- 4.5MM X 14MM X 135CM-4.5MM X 19MMOstial Corporation·2012-06-29
• K121681 — GLIDER PTCA BALLOON CATHETERTrireme Medical, Inc.·2012-06-26
• K121222 — TREK OTW CORONARY DILATATION CATHETER MINI TREK OTW CORONARY DILATATION CATHETERAbbott Vascular·2012-06-22
• K113220 — EMERGE PTCA DILATATION CATHETER (MONORAIL) EMERGE PTCA DILATATION CATHETER (OVER-THE-WIRE)Boston Scientific Corporation·2012-03-22
• K113464 — NC TREK OTW CORONARY DILATATION CATHETERAbbott Vascular·2012-03-06
• K111544 — GLIDER PTCA BALLOON CATHETERTrireme Medical, Inc.·2012-03-02
• K103808 — SAPPHIRE NCOrbusneich Medical, Inc.·2011-09-01
• K111284 — FLASH-C PTCA BALLOON DILATION CATHETER - 5MM X 19MM X 135CM / 6MM X 19MM X 135CMOstial Corporation·2011-08-17
• K103657 — SAPPHIREOrbusneich Medical, Inc.·2011-08-09
• K110133 — EMPIRA RX PTCA DILATATION CATHETER, EMPRIA NC RX PTCA DILATATION CATHETERCreganna-Tactx Medical·2011-06-10
• K110617 — MINI TREK RX 1.20 MM CORONARY DILATATION CATHETER, MINI TREK OTW 1.20 MM CORONARY DILATATION CATHETERAbbott Vascular·2011-06-02
• K110134 — NC TREK RX CORONARY DILATATION CATHETERAbbott Vascular-Cardiac Therapies·2011-02-11
• K103110 — MINI TREK(TM) RX AND TREK(TM) RX CORONARY DILATATION CATHETER MINI TREK(TM) OTW AND TREK(TM) OTW DILATATION CATHETERAbbott Vascular-Cardiac Therapies·2011-01-10
• K103153 — VOYAGER NC CORONARY DILATATION CATHETER AND NC TREK RX CORONARY DILATATION CATHETERAbbott Vascular-Cardiac Therapies·2010-12-30
• K103095 — SPRINTER LEGEND 1.25MM RX AND SPRINTER LEGEND 1.25MM OTW BALLOONMedtronic, Ireland·2010-10-22
• K896108 — THE PILOT SCIMED TORQUE DEVICEScimed Life Systems, Inc.·1990-01-09
• K861847 — ACS ROTATING HEMO VALVE - DUAL ACCESS TYPEAdvanced Cardiovascular Systems, Inc.·1986-06-16
• K843944 — PTCA BALLOON CATHETERS & ACCESSORIESAdvanced Cardiovascular Systems, Inc.·1985-02-14
• K820410 — HEMOTEC HEPCON/SYSTEM FOUR & FOUR PHemotec, Inc.·1982-04-09