MJN
RenovoCath
- Advisory panel
- Cardiovascular
- Total cleared
- 90
Adverse events under product code MJN
product code MJN- Death
- 31
- Injury
- 240
- Malfunction
- 827
- Total
- 1,098
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code MJN
- K243795 — pREBOA-PRO Catheter
- K251358 — Bridge Plus Occlusion Balloon (590-002)
- K221294 — preCARDIA Occlusion System
- K214060 — LANDMARK REBOA Catheter
- K211610 — Fogarty Occlusion Catheter
- K212324 — RenovoCath
- K210602 — AortaSTAT Occlusion Device
- K210358 — Neurescue device
- K201652 — COBRA-OS Kit
- K203540 — Bridge Occlusion Balloon
- K200459 — pREBOA-PRO Catheter
- K192786 — Gatekeeper Balloon Catheter
- K193440 — ER-REBOA PLUS Catheter
- K191606 — RenovoCath
- K183045 — Eclipse 2L
- K183679 — Occlusion Balloon Catheter
- K182916 — Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3 Carotid Shunt, 8 Fr
- K180904 — Sniper Infusion Catheter with Balloon Occlusion
- K172567 — GORE Molding and Occlusion Balloon Catheter
- K172790 — ER-REBOA Catheter
- K170411 — ER-REBOA Catheter
- K160067 — RenovoCath
- K160598 — REBOA Balloon Catheter
- K153530 — Bridge Occlusion Balloon
- K152833 — Pruitt F3-S Polyurethane Carotid Shunt
- K152762 — Fogarty Occlusion Catheter
- K143454 — Pruitt F3-S Carotid Shunt
- K143613 — PaxWire Occlusion Balloon System
- K142692 — Occlusion Balloon Catheter
- K141175 — RENOVOCATH RC120
- K140273 — EQUALIZER OCCLUSION BALLOON CATHETER
- K132022 — LEMAITRE 8F OCCLUSION CATHETER
- K132990 — OCCLUSION BALLOON CATHETER
- K131869 — PTS-X SIZING BALLOON CATHETER
- K122576 — TRANSFORM OCCLUSION BALLOON CATHETER (COMPLIANT AND SUPER COMPLIANT
- K121785 — SCEPTER C OCCLUSION BALLOON CATHETER
- K113698 — SCEPTER XC OCCLUSION BALLOON CATHETER
- K112219 — TAPAS CATHETER
- K110741 — SCEPTER C OCCLUSION BALLOON CATHETER
- K110903 — PTS-X SIZING BALLOON CATHETER
- K103780 — MICRUS ASCENT OCCLUSION BALLOON CATHETER 4X7 MM; MICRUS ASCENT OCCLUSION BALLOON CATHETER 6X9 MM; MICRUS SUMMIT OCCLUSIO
- K103356 — PRUITT CAROTID KIT
- K093847 — DUFLO CATHETER (HEPARIN COATED)
- K101570 — HYPERGLIDE AND HYPERFORM OCCLUSION BALLOON SYSTEMS
- K100063 — HYPERFORM OCCLUSION BALLOON CATHETER, HYPERGLIDE OCCLUSION BALLOON CATHETER, HYPERGLIDE OCCLUSION BALLOON CATHETER MODEL
- K093911 — FOGARTY OCCLUSION CATHETER
- K091458 — HYPERGLIDE OCCLUSION BALLOON SYSTEM, HYPERFORM OCCLUSION BALLOON SYSTEM, MODEL 104-4112, 104-4113, 104-4127,104-4132,104
- K092495 — HYPERGLIDE OCCLUSION BALLOON SYSTEM, MODEL 104-4310, 104-4315
- K091504 — MICRUS ASCENT OCCLUSION BALLOON CATHETER 4X7MM,6X9MM, MICRUS SUMMIT OCCLUSION BALLOON CATHETER 4X10MM,4X15, MODEL BRS 00
- K090970 — FLOCONTROL , MODEL 1028
- K090728 — HYPERGLIDE OCCLUSION BALLOON SYSTEM
- K080700 — DUOFLO CATHETER
- K080861 — MICRUS ASCENT OCCLUSION BALLOON CATHETER
- K081454 — GUARDDOG OCCLUSION GUIDEWIRE, INFLATION DEVICE
- K071367 — FLEXCEL CAROTID SHUNT (INLYING), MODEL 2020-05
- K070770 — GORE BALLOON SHEATH
- K062220 — MODIFICATION TO GUARDDOG OCCLUSION SYSTEM
- K052844 — KAVS - CATHETER, MODELS 1107100 & 1107060
- K051137 — TECHDEVICE OCCLUSION BALLOON CATHETER
- K053440 — AMPLATZER SIZING BALLOON II
- K051067 — PRUITT F3 OUTLYING AND INLYING CAROTID SHUNT (WITH AND WITHOUT T-PORT)
- K043023 — PRUITT-INAHARA OUTLYING CAROTID SHUNT, MODELS, 2012-49, 2013-49, 2014-49,2015-49,2016-49, 2017-49
- K041306 — NUMED PTS X SIZING BALLOON CATHETER
- K031357 — GUARDDOG OCCLUSION SYSTEM, OCCLUSION GUIDEWIRE, 300 CM, GUARDDOG OCCLUSION SYSTEM OCCLUSION GUIDEWIRE, 200 CM
- K033159 — LEMAITRE VASCULAR STRAIGHT CAROTID SHUNT, MODEL 2002-01, 2002-05, 2003-01, 2003-05, 2004-01, 2004-05, 2005-01, 2005-05
- K023914 — COAXIA FLOCONTROL CATHETER
- K021210 — ARTERIA OCCLUSION BALLOON
- K021066 — MODIFICATION TO HYPERGLIDE OCCLUSION BALLOON SYSTEM
- K011535 — CADENCE PRECISION INJECTOR, MODEL 103-0304
- K011656 — HYPERFORM OCCLUSION BALLOON SYSTEM, MODEL 104-4470, 104-4471, 104-4770, 104-4771
- K011526 — HYPERGLIDE OCCLUSION BALLOON SYSTEM, MODEL 104-4118, 104-4121, 104-4129, 104-4126, 104-4115, 104-4123
- K001917 — PARODI CATHETER FOR ANGIOGRAPHY (PARCA)
- K010162 — EQUINOX OCCULSION BALLOON SYSTEM MODEL # 104-4015, 104-4018, 104-4021, 104-4023, 104-4026
- K003320 — PTA-OS SIZING BALLOON, MODEL 360
- K002286 — LDOB OCCLUSION BALLOON CATHETER
- K001621 — DARDIK CAROTID SHUNT
- K994141 — CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY, MODEL SOL 3510; WIRE, GUIDE, CATHETER, MODEL QSW1000
- K993248 — AMPLATZER SIZING BALLOON
- K001237 — EQUINOX OCCLUSION BALLOON CATHETER/SYSTEM - (10MM BALLOON, 4 & 13 MM TIP), (15 MM BALLOON, 4 & 13 MM TIP), (20 MM BALLOO
- K992942 — LEMAITRE OCCLUSION CATHETER
- K993292 — BOSTON SCIENTIFIC/TARGET SENTRY OCCLUSION BALLOON CATHETER
- K990487 — EQUINOX OCCLUSION BALLOON SYSTEM
- K983802 — LMI CAROTID ENDARTERECTOMY SHUNT CATHETER, MODEL #'S CES, CESR, CESB, CESRB, CEST, CESTR, CESTB, CESTRB, CES-SB, CESR-SB
- K972777 — TEMPORARY OCCLUSION BALLOON SYSTEM
- K964390 — CHASE VESSEL OCCLUDER
- K960715 — PRUITT-INAHARA CAROTID SHUNT 400-40-8F/INAHARA-PRUITT CAROTID SHUNT 500-50-8F
- K960422 — PRUITT SAFETY OCCLUSION CATHETER
- K960832 — OCCLUSION BALLOON CATHETER
- K955499 — LMI BILUMEN IRRIGATION ARTERIAL EMBOLECTOMY CAHTETER
- K915869 — RMI NORMOCLUDER CORONARY ARTERY OCCLUDER
Data sourced from openFDA. This site is unofficial and independent of the FDA.