Catheters, Transluminal Coronary Angioplasty, Percutaneous
Cardiovascular · 21 CFR 870.5100
A PTCA catheter is a device that operates on the principle of hydraulic pressurization applied through an inflatable balloon attached to the distal end.
Recent MDR events
43,512 adverse event reports on file
- NC TREK NEO¿Jul 31, 2026MalfunctionAbbott Vascular Inc.2024168-2026-03028
- NC TREK NEO¿Jul 30, 2026MalfunctionAbbott Vascular Inc.2024168-2026-03018
- EUPHORA RXJul 30, 2026InjuryMedtronic Mexico S. De R.l. De Cv9617601-2026-04638
- EUPHORA RXJul 30, 2026InjuryMedtronic Mexico S. De R.l. De Cv9617601-2026-04639
- Emerge?Jul 30, 2026DeathBoston Scientific Corporation2124215-2026-41077
- MINI TREK¿Jul 29, 2026MalfunctionAbbott Vascular Inc.2024168-2026-03001
- NC EmergeJul 29, 2026MalfunctionBoston Scientific Corporation2124215-2026-40522
- NC EmergeJul 29, 2026MalfunctionBoston Scientific Corporation2124215-2026-40524
- NC EmergeJul 29, 2026MalfunctionBoston Scientific Corporation2124215-2026-40525
- Emerge?Jul 29, 2026MalfunctionBoston Scientific Corporation2124215-2026-40587
Event type breakdown
Recalls
121 recall events for this product code
- Abbott VascularTerminatedFeb 14, 2020
NC TREK Coronary Dilatation Catheter, REF 1012453-08 Rx Only, NC TREK RX 4.00 X 8MM BDC
Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Z-1128-2020 · View FDA record ↗ - Abbott VascularTerminatedFeb 14, 2020
NC TREK Coronary Dilatation Catheter, REF 1012453-12 Rx Only, NC TREK RX 4.00 X 12MM BDC
Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Z-1129-2020 · View FDA record ↗ - Abbott VascularTerminatedFeb 14, 2020
NC TREK Coronary Dilatation Catheter, REF 1012453-15 Rx Only, NC TREK RX 4.00 X 15MM BDC
Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Z-1130-2020 · View FDA record ↗ - Abbott VascularTerminatedFeb 14, 2020
NC TREK Coronary Dilatation Catheter, REF 1012453-20 Rx Only, NC TREK RX 4.00 X 20MM BDC
Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Z-1131-2020 · View FDA record ↗ - Abbott VascularTerminatedFeb 14, 2020
NC TREK Coronary Dilatation Catheter, REF 1012453-20 Rx Only, NC TREK RX 4.50 X 8MM BDC
Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Z-1132-2020 · View FDA record ↗ - Abbott VascularTerminatedFeb 14, 2020
NC TREK Coronary Dilatation Catheter, REF 1012453-20 Rx Only, NC TREK RX 4.50 X 8MM BDC
Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Z-1133-2020 · View FDA record ↗ - Abbott VascularTerminatedFeb 14, 2020
NC TREK Coronary Dilatation Catheter, REF 1012454-15 Rx Only, NC TREK RX 4.50 X 15MM BDC
Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Z-1134-2020 · View FDA record ↗ - Abbott VascularTerminatedFeb 14, 2020
NC TREK Coronary Dilatation Catheter, REF 1012454-20 Rx Only, NC TREK RX 4.50 X 20MM BDC
Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Z-1135-2020 · View FDA record ↗ - Abbott VascularTerminatedFeb 14, 2020
NC TREK Coronary Dilatation Catheter, REF 1012455-08 Rx Only, NC TREK RX 5.00 X 8MM BDC
Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Z-1136-2020 · View FDA record ↗ - Abbott VascularTerminatedFeb 14, 2020
NC TREK Coronary Dilatation Catheter, REF 1012455-12 Rx Only, NC TREK RX 5.00 X 12MM BDC
Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Z-1137-2020 · View FDA record ↗
Registered firms
248 firms currently registered for this product code
Brosmed Medical Co.,ltd
Dongguan Guangdong, CN
Boston Scientific Corporation
Saint Paul, MN, US
Shanghai Microport Medical (group) Co., Ltd
Shanghai, CN
Boston Scientific Limited
GALWAY, IE
Wuxi Goals Medical Technology Co., Ltd.
Yixing Jiangsu, CN
Sterigenics Costa Rica S.r.l.
El Coyol Alajuela, CR
Suzhou Prosteri Medical Technology Co., Ltd.
Suzhou Jiangsu, CN
Teleflex Medical Llc
Morrisville, NC, US
Meril Inc
Bethlehem, PA, US
Shanghai Microport Medical (group) Co., Ltd
Shanghai, CN
Lepu Medical Technology (beijing) Co., Ltd
Beijing, CN
Boston Scientific Medical Device (malaysia) Sdn Bhd
Taman Perindustrian Batu Kawan Pulau Pinang, MY
Terumo Corp.
SHIBUYA-KU, TOKYO, JP
Sterigenics Us Llc
Los Angeles, CA, US
Medtronic Mexico S. De R.l. De Cv
Tijuana Baja California, MX
Abbott Vascular
El Coyol Alajuela, CR
Abbott Vascular
Temecula, CA, US
Teleflex Medical De Tecate, S. De R.l De C.v.
TECATE Baja California, MX
Medinol Ltd.
Jerusalem, IL
Synergy Health Ast, Srl
Alajuela, CR
Beijing Target Medical Technologies Inc.
Beijing, CN
Abbott Vascular Netherlands
Heerlen Limburg, NL
510(k) clearances
87 clearances for this product code
- Medtronic IrelandJul 27, 2026
K261759 · Euphora Rapid Exchange (RX) Balloon Dilatation Catheter
- Shanghai MicroPort Medical (Group) Co., Ltd.Apr 7, 2026
K252116 · Firefighter Pro PTCA Balloon Catheter
- Verge Medical, Inc.Apr 2, 2026
K254022 · FLASH Flex Aorto-Ostial Angioplasty System
- Terumo CorporationMar 27, 2026
K252295 · Ryurei
- Medtronic, IrelandJan 17, 2026
K251970 · Sprinter Legend Rapid Exchange Balloon Dilatation Catheter
- Biotronik, Inc.Oct 25, 2024
K242969 · Pantera Pro; Pantera LEO
- OrbusNeich Medical (Shenzhen) Co., Ltd.Aug 16, 2024
K233499 · Sapphire NC ULTRA Coronary Dilatation Catheter
- OrbusNeich Medical (Shenzhen) Co., Ltd.Aug 15, 2024
K233505 · Sapphire ULTRA Coronary Dilatation Catheter
PMA approvals
20 premarket approvals for this product code
- Abbott Vascular, Inc.Jun 11, 2003
P020037 · FX MINIRAIL RX PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER
- Cook, Inc.Sep 27, 1999
P990008 · COOK MBC PTCA BALLOON DILATATION CATHETER
- Global Therapeutics, Inc.Oct 5, 1998
P960014 · MAGELLAN-C PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY(PTCA) CATHETERS MODEL C22020,C22520,C23020,& C23520
- Endologix, Inc.Feb 20, 1998
P970052 · FACT, ARC, LYNX AND GUARDIAN BALLOON CORONARY DILATATION CATHETERS
- Abbott Vascular DevicesSep 30, 1994
P910031 · ORACLE(TM) CORONARY BALLOON DILATATION CATHETER
- Scimed Life Systems, Inc.Sep 29, 1994
P940009 · PERCUTANEUS TRANSLUMINAL CORONARY ANGIOPLASTY CATH
- Usci, Div. C.R. Bard, Inc.Apr 17, 1991
P890048 · USCI PROBE III BALLOON-ON-A-WIRE DILATATION SYSTEM
- Boston Scientific CorpSep 26, 1990
P880055 · CORONARY BALLOON DILATATION CATHETER