Product code LIT— Cardiovascular
PTA BALLOON CATHETER
- Advisory panel
- Cardiovascular
- Total cleared
- 403
Adverse events under product code LIT
product code LIT- Death
- 27
- Injury
- 1,256
- Malfunction
- 12,127
- Total
- 13,410
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 LIT
1–100 of 403- K260304 — WAVE PTA Balloon Catheter
- K252512 — Armada 14 NC PTA Catheter
- K251915 — Amethyst HP PTA OTW 0.035 Catheter
- K250706 — Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters; Passeo-14 Peripheral Dilatation Catheter; Oscar Peripheral Multifunctional Catheter System; Pantera Pro Percutaneous Transluminal Coronary Angioplasty Catheter; Pantera LEO Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter
- K243704 — Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon Dilatation Catheter; Parafleet SC 035 PTA Balloon Dilatation Catheter
- K241040 — Amethyst HP PTA OTW 0.035 Catheter
- K242419 — 018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter
- K241740 — Finesse Injectable PTA Balloon Dilatation Catheter
- K241711 — Oscar Peripheral Multifunctional Catheter system
- K241683 — Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031404020 ); Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031406020); Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031408020); Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031410020); Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031412020); Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031415020); Sterling MONORAIL PTA Balloon Dilatation Catheter (H749390314
- K241025 — JADE PLUS PTA Balloon Dilatation Catheter
- K231402 — HP PTA Balloon Dilatation Catheter
- K230263 — Finesse Injectable PTA Balloon Dilatation Catheter
- K214009 — D·Kaptain PTA High Pressure Balloon Dilatation Catheter
- K230191 — Arise UHP Dilatation Catheter
- K222065 — Passeo-35 Xeo Peripheral Dilatation Catheter
- K223177 — Highlander 014 PTA Balloon Dilatation Catheter
- K221245 — PTA Balloon Dilatation Catheter
- K221414 — ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter
- K221832 — SABER .014 PTA Dilatation Catheter; SABERX .014 PTA Dilatation Catheter
- K212215 — Tiche PTA Balloon Dilatation Catheter
- K214038 — Oscar Peripheral Multifunctional Catheter system
- K220410 — Ebony HP PTA OTW 0.035 Catheter
- K221339 — Paladin Carotid Post-Dilation Balloon System with Integrated Embolic Protection
- K221057 — Viatrac 14 Plus Peripheral Dilatation Catheter
- K213631 — Chocolate PTA Balloon Catheter
- K201246 — PTA Balloon Catheter (PVQ), MIT PTA Balloon Catheter (PVQ)
- K211044 — Sublime Radial Access 018 RX Dilatation Catheter
- K210626 — SABER .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter
- K202231 — JADE
- K202800 — Pacific Plus PTA Catheter
- K201377 — SABERX RADIANZ Percutaneous Transluminal Angioplasty Dilatation Catheter
- K201170 — Athletis PTA Balloon Dilatation Catheter
- K201333 — SABER .035 PTA Dilatation Catheter
- K201794 — Jade
- K192399 — Infinity Angioplasty Balloon Catheter
- K200700 — Surmodics Sublime Radial Access 014 RX PTA (Percutaneous Transluminal Angioplasty) Dilatation Catheter
- K191275 — AllInCath 035M PTA Balloon Dilatation Catheter
- K192907 — Advocate PTA Catheter
- K190037 — Cronus HP PTA Balloon Catheter
- K192318 — Ultraverse 014 and 018 PTA Balloon Dilatation Catheters
- K190753 — EverCrossTM 0.035 OTW PTA Dilatation Catheter
- K181529 — Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection
- K181128 — Paladin Carotid Post-dilation Balloon System with Integrated Embolic Protection (Paladin System)
- K181323 — Atlas Gold PTA Dilatation Catheter
- K180007 — 018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter
- K173515 — Admiral Xtreme
- K173894 — Jade PTA Balloon Dilatation Catheter
- K172494 — PROTEUS PTA Balloon Catheter with Embolic Capture Feature
- K173621 — Advocate PTA Catheter
- K171251 — 014 Hydrophilic Coated PTA Balloon Dilatation Catheter
- K172033 — Pirouette High Pressure (HP)
- K171290 — Vela RX PTA Balloon Dilatation Catheter
- K170635 — Chameleon PTA Balloon Catheter
- K170193 — Advance 14LP Low Profile PTA Balloon Dilatation Catheter
- K163231 — Chameleon PTA Balloon Catheter
- K163479 — R2P Metacross RX
- K160941 — Castor, Achilles and Hermes NC PTA Balloon Dilatation Catheter
- K162316 — Pirouette 014
- K162350 — Coyote Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Express SD Biliary Monorail Premounted Stent System, Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Catheter, Sterling Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Ultra-Soft SV Monorail Balloon Dilatation Catheter 0.018
- K161427 — Pirouette 035
- K160256 — Polux , Minerva and Atropos PTA Balloon Dilatation Catheter
- K160004 — Crosstella OTW
- K160013 — Crosperio OTW
- K152934 — MMS PTA Balloon Catheter
- K152873 — Crosstella RX Balloon Dilatation Catheter
- K152887 — Crosperio RX PTA Balloon Dilatation Catheter
- K151141 — Cronus HP - High Pressure Peripheral Balloon Catheter
- K152665 — PolarCath Peripheral Dilatation System
- K151744 — Passeo-18 Peripheral Dilation Catheter
- K152240 — Passeo-14 Peripheral Dilatation Catheter
- K152080 — Metacross OTW PTA Balloon Dilatation Catheter
- K151678 — Chameleon PTA Balloon Catheter
- K152230 — Ebony PTA .014 RX Pheripheral Dilatation Catheter
- K151153 — Pirouette 018
- K150452 — ComboCath OTW PTA Dilatation Catheter
- K143193 — Symmetry and Symmetry Stiff Shaft Balloon Dilatation Catheters
- K151317 — Armada 18 PTA Catheter
- K143093 — 0.018 Arrow GPSCath Balloon Dilatation Catheter (150 cm)
- K150303 — XXL Vascular Balloon Dilatation Catheter
- K143041 — Ebony PTA 0.014'' over the wire Catheter and Ebony PTA 0.018 over the wire Catheter
- K142954 — PTA 14 Balloon Dilatation Catheter OTW
- K143561 — ELM PTA Balloon Dilatation Catheter
- K150946 — FLASH Ostial System OTW-6.0mm x 12mm x 80cm, FLASH Ostial System OTW-6.0mm x 12mm x 135cm, FLASH Ostial System OTW-7.0mm x 12mm x 80cm, FLASH Ostial System OTW-7.0mm x 12mm x 135cm
- K143036 — Ebony PTA 0.035 Peripheral Dilatation Catheter
- K143652 — Vector PTA Balloon Dilatation Catheter
- K142459 — Ebony PTA 0.014 RX Peripheral Dilatation Catheter
- K142379 — Passeo-35 PTA Catheter
- K142654 — Fortrex 0.035 OTW PTA Balloon Catheter
- K141150 — PTA BALLOON DILATATION CATHETER
- K142261 — Ultraverse 035 PTA Balloon Dilatation Catheter
- K142300 — Arrow GPSCath Balloon Dialation Catheter (150 cm)
- K141521 — MUSTANG BALLOON DILATATION CATHETER/CHARGER PTA BALLOON DILATATION CATHETER
- K141118 — NANOCROSS EITE 0.014 OVER-THE-WIRE PTA BALLOON DILATATION CATHETER
- K141112 — STERLING OVER-THE WIRE PTA BALLOON DILATATION CATHETER
- K133861 — FLASH OSTIAL SYSTEM OTW-7.0MMX17MMX135CM, FLASH OSTIAL SYSTEM OTW-7.0MMX17MMX80CM
- K140351 — ARROW GPSCATH BALLOON DILATATION CATHETER
- K133843 — SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY DILATATION CATHETER
- K132810 — GLADIATOR ELITE PTA BALLOON DILATATION CATHETER
- K133043 — PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE
Data sourced from openFDA. This site is unofficial and independent of the FDA.