Product code LOX
- Device name
- Catheters, Transluminal Coronary Angioplasty, Percutaneous
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.5100
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- A PTCA catheter is a device that operates on the principle of hydraulic pressurization applied through an inflatable balloon attached to the distal end.
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P860019S264 | APEX MONORAIL & APEX OTW PTCA DILATATION CATHETER/MAVERICK2 MONORAIL PTCA CATHETER/MAVERICK OTW PTCA CATHETER/MAVERICK | Scimed Life Systems, Inc. | 2011-03-31 |
| P950020S040 | FLEXTOME CUTTING BALLOON | Boston Scientific Corp | 2011-01-07 |
| P790017S110 | GRUNTZIG DILACA BALLOON DILATATION CATHETERS | Medtronic, Ireland | 2010-10-27 |
| P790017S106 | GRUNTZIG DILACA BALLOON DILATATION CATHETERS | Medtronic, Ireland | 2010-10-19 |
| P810046S240 | CORONARY DILATATION CATHETERS | Advanced Cardiovascular Systems, Inc. | 2010-10-15 |
| P790017S109 | GRUNTZIG DILACA BALLOON DILATATION CATHETERS | Medtronic, Ireland | 2010-09-14 |
| P860019S263 | APEX PTCA & NC QUANTUM APEX PTCA CATHETERS | Scimed Life Systems, Inc. | 2010-09-08 |
| P860019S261 | MAVERICK2 MONORAIL PTCA DILATATION CATHETER | Scimed Life Systems, Inc. | 2010-09-08 |
| P860019S260 | PTCA CATHETERS (MAVERICK2/MAVERICK/MAVERICK XL/QUANTUM/MAVERICK/APEX) | Scimed Life Systems, Inc. | 2010-09-01 |
| P860019S259 | PTCA CATHETERS | Scimed Life Systems, Inc. | 2010-08-13 |
| P860019S258 | BSC APEX MONORAIL & OTW PTCA DILATATION CATHETERS | Scimed Life Systems, Inc. | 2010-07-28 |
| P790017S108 | GRUNTZIG DILACA BALLOON DILATATION CATHETERS | Medtronic, Ireland | 2010-07-01 |
| P860019S256 | MAVERICK2 MONORAIL & MAVERICK OTW PTCA DILATATION CATHETERS | Scimed Life Systems, Inc. | 2010-06-23 |
| P790017S104 | GRUNTZIG DILACA BALLOON DILATATION CATHETERS | Medtronic, Ireland | 2010-06-04 |
| P810046S237 | VOYAGER NC CORONARY DILATATION CATHETER | Advanced Cardiovascular Systems, Inc. | 2010-06-01 |
| P860019S255 | APEX PTCA DILATATION CATHETER | Scimed Life Systems, Inc. | 2010-05-27 |
| P810046S238 | VOYAGER NC CORONARY DILATATION CATHETER | Advanced Cardiovascular Systems, Inc. | 2010-05-13 |
| P860019S252 | QUANTUM MAVERICK OTW/APEX OTW/MAVERICK OTW/MAVERICK XL MONORAIL PTCA DILATATION CATHETERS | Scimed Life Systems, Inc. | 2010-05-11 |
| P860019S253 | MAVERICK 2 MONORAIL PTCA CATHETER | Scimed Life Systems, Inc. | 2010-04-22 |
| P790017S107 | SPRINTER LEGEND RX BALLOON DILATATION CATHETER | Medtronic, Ireland | 2010-04-21 |
| P860019S241 | NC QUANTUM APEX MONORAIL AND OVER-THE-WIRE PTCA CATHETERS | Scimed Life Systems, Inc. | 2010-04-16 |
| P950020S039 | CORONARY FLEXTOME CUTTING BALLOON | Boston Scientific Corp | 2010-04-06 |
| P860019S251 | MAVERICK XL PTCA DILATATION CATHETER | Scimed Life Systems, Inc. | 2010-04-06 |
| P950020S035 | CORONARY FLEXTONE CUTTING BALLOON | Boston Scientific Corp | 2010-03-18 |
| P860019S250 | PTCA CATHETERS | Scimed Life Systems, Inc. | 2010-03-01 |
| P950020S037 | FLEXTOME CUTTING BALLOON | Boston Scientific Corp | 2010-02-25 |
| P860019S248 | MAVERICK2 PTCA CATHETER/APEX PTCA CATHETER | Scimed Life Systems, Inc. | 2010-02-25 |
| P950020S038 | FLEXTOME CUTTING BALLOON DILATATIONS DEVICE | Boston Scientific Corp | 2010-02-22 |
| P860019S249 | PTCA CATHETERS | Scimed Life Systems, Inc. | 2010-02-22 |
| P860019S247 | MAVERICK OVER-THE WIRE PTCA CATHETER | Scimed Life Systems, Inc. | 2010-02-01 |
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252116 | Firefighter™ Pro PTCA Balloon Catheter | Shanghai MicroPort Medical (Group) Co., Ltd. | 2026-04-07 |
| K254022 | FLASH Flex™ Aorto-Ostial Angioplasty System | Verge Medical, Inc. | 2026-04-02 |
| K252295 | Ryurei | Terumo Corporation | 2026-03-27 |
| K251970 | Sprinter Legend Rapid Exchange Balloon Dilatation Catheter | Medtronic, Ireland | 2026-01-17 |
| K242969 | Pantera Pro; Pantera LEO | Biotronik, Inc. | 2024-10-25 |
| K233499 | Sapphire NC ULTRA Coronary Dilatation Catheter | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2024-08-16 |
| K233505 | Sapphire ULTRA Coronary Dilatation Catheter | OrbusNeich 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 ... | Vascular Solutions, LLC | 2024-05-31 |
| K223189 | Firefighter™ NC Pro PTCA Balloon Catheter | Shanghai 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 Catheter | Brosmed Medical Co., Ltd. | 2023-04-11 |
| K223022 | SC HONKYTONK PTCA Balloon Dilatation Catheter | Sino Medical Sciences Technology, Inc. | 2023-02-15 |
| K222538 | NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter | Sino Medical Sciences Technology, Inc. | 2022-12-21 |
| K220634 | NC TREK NEO Coronary Dilatation Catheter | Abbott Vascular | 2022-06-30 |
| K220629 | Emerge Monorail PTCA Dilatation Catheter | Boston Scientific | 2022-03-24 |
| K212393 | OPN NC PTCA Dilatation Catheter | Sis Medical AG | 2022-03-14 |
| K211349 | Selebrek PTCA Balloon Dilatation Catheter | Kossel Medtech (Suzhou) Co., Ltd. | 2022-01-07 |
| K211807 | Sapphire NC 24 | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2021-10-14 |
| K210012 | Tamarin Blue PTCA RX Dilatation Catheter | Natec Medical , Ltd. | 2021-07-09 |
| K211393 | Selethru(TM) NC PTCA Balloon Dilatation Catheter | Kossel Medtech (Suzhou) Co., Ltd. | 2021-07-02 |
| K202578 | KardiFlex NC Coronary Dilatation Catheter | Medcaptain Life Science Co., Ltd. | 2021-05-06 |
| K202619 | KardiFlex PTCA Balloon Dilatation Catheter | Medcaptain Life Science Co., Ltd. | 2021-04-29 |
| K203390 | Artimes pro Balloon Dilatation Catheter | Brosmed Medical Co., Ltd. | 2021-04-14 |
| K200269 | Sapphire II PRO | Orbusneich Medical Trading, Inc. | 2020-03-04 |
| K192344 | Sapphire NC Plus Coronary Dilatation Catheter | Orbusneich Medical Trading, Inc. | 2019-09-19 |
| K182699 | Selethru PTCA Balloon Dilatation Catheter | Kossel 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 Dilat... | Abbott Vascular | 2018-08-24 |
| K180921 | Sapphire II PRO Balloon Dilatation Catheter | Orbusneich Medical Trading, Inc. | 2018-06-28 |
| K181023 | Mozec – Rx PTCA Balloon Dilatation Catheter, Mozec NC – Rx PTCA Balloon Dilatation Catheter | Meril Life Sciences Private Limited | 2018-05-17 |
| K172264 | OTW Takeru PTCA Balloon Dilatation Catheter | KANEKA Corporation | 2018-03-19 |
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| 07640142572886 | OPN NC | SIS Medical AG | 2022-12-12 |
| 07640142572879 | OPN NC | SIS Medical AG | 2022-12-12 |
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| 07640142570561 | OPN NC | SIS Medical AG | 2022-12-12 |
| 07640142570578 | OPN NC | SIS Medical AG | 2022-12-12 |
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| 10193489078015 | NAMIC | MEDLINE INDUSTRIES, INC. | 2021-07-26 |
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| H74902470010 | NAMIC | NAVILYST MEDICAL, INC. | 2016-09-20 |