FDA Product Code
FDA Product Code LOX — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.5100
510(k) Clearances — 88 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261428 | NC Euphora Rapid Exchange Balloon Dilatation Catheter | Medtronic Ireland | 2026-08-14 | Traditional | PDF ↗ |
| K261759 | Euphora Rapid Exchange (RX) Balloon Dilatation Catheter | Medtronic Ireland | 2026-07-27 | Traditional | PDF ↗ |
| K252116 | Firefighter Pro PTCA Balloon Catheter | Shanghai MicroPort Medical (Group) Co., Ltd. | 2026-04-07 | Traditional | PDF ↗ |
| K254022 | FLASH Flex Aorto-Ostial Angioplasty System | Verge Medical, Inc. | 2026-04-02 | Traditional | PDF ↗ |
| K252295 | Ryurei | Terumo Corporation | 2026-03-27 | Traditional | PDF ↗ |
| K251970 | Sprinter Legend Rapid Exchange Balloon Dilatation Catheter | Medtronic, Ireland | 2026-01-17 | Traditional | PDF ↗ |
| K242969 | Pantera Pro; Pantera LEO | Biotronik, Inc. | 2024-10-25 | Special | PDF ↗ |
| K233499 | Sapphire NC ULTRA Coronary Dilatation Catheter | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2024-08-16 | Traditional | PDF ↗ |
| K233505 | Sapphire ULTRA Coronary Dilatation Catheter | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2024-08-15 | Traditional | PDF ↗ |
| 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 (58 | Vascular Solutions, LLC | 2024-05-31 | Traditional | PDF ↗ |
| K223189 | Firefighter NC Pro PTCA Balloon Catheter | Shanghai MicroPort Medical (Group) Co., Ltd. | 2023-07-21 | Traditional | PDF ↗ |
| K230374 | Coronary Dilatation Balloon Catheter (VesPenetrator®), Coronary Dilatation Balloon Catheter (VesTraveler®), Coronary Dilatation Balloon Catheter (VexPander®) | Dongguan TT Medical, Inc. | 2023-06-29 | Traditional | PDF ↗ |
| K230705 | POT PTCA Balloon Dilatation Catheter | Brosmed Medical Co., Ltd. | 2023-04-11 | Special | PDF ↗ |
| K223022 | SC HONKYTONK PTCA Balloon Dilatation Catheter | Sino Medical Sciences Technology, Inc. | 2023-02-15 | Traditional | PDF ↗ |
| K222538 | NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter | Sino Medical Sciences Technology, Inc. | 2022-12-21 | Traditional | PDF ↗ |
| K220634 | NC TREK NEO Coronary Dilatation Catheter | Abbott Vascular | 2022-06-30 | Traditional | PDF ↗ |
| K220629 | Emerge Monorail PTCA Dilatation Catheter | Boston Scientific | 2022-03-24 | Special | PDF ↗ |
| K212393 | OPN NC PTCA Dilatation Catheter | Sis Medical AG | 2022-03-14 | Traditional | PDF ↗ |
| K211349 | Selebrek PTCA Balloon Dilatation Catheter | Kossel Medtech (Suzhou) Co., Ltd. | 2022-01-07 | Traditional | PDF ↗ |
| K211807 | Sapphire NC 24 | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2021-10-14 | Traditional | PDF ↗ |
| K210012 | Tamarin Blue PTCA RX Dilatation Catheter | Natec Medical , Ltd. | 2021-07-09 | Special | PDF ↗ |
| K211393 | Selethru(TM) NC PTCA Balloon Dilatation Catheter | Kossel Medtech (Suzhou) Co., Ltd. | 2021-07-02 | Traditional | PDF ↗ |
| K202578 | KardiFlex NC Coronary Dilatation Catheter | Medcaptain Life Science Co., Ltd. | 2021-05-06 | Traditional | PDF ↗ |
| K202619 | KardiFlex PTCA Balloon Dilatation Catheter | Medcaptain Life Science Co., Ltd. | 2021-04-29 | Traditional | PDF ↗ |
| K203390 | Artimes pro Balloon Dilatation Catheter | Brosmed Medical Co., Ltd. | 2021-04-14 | Traditional | PDF ↗ |
| K200269 | Sapphire II PRO | Orbusneich Medical Trading, Inc. | 2020-03-04 | Special | PDF ↗ |
| K192344 | Sapphire NC Plus Coronary Dilatation Catheter | Orbusneich Medical Trading, Inc. | 2019-09-19 | Special | PDF ↗ |
| K182699 | Selethru PTCA Balloon Dilatation Catheter | Kossel Medtech (Suzhou) Co., Ltd. | 2018-11-26 | Traditional | PDF ↗ |
| 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 Catheter | Abbott Vascular | 2018-08-24 | Special | PDF ↗ |
| K180921 | Sapphire II PRO Balloon Dilatation Catheter | Orbusneich Medical Trading, Inc. | 2018-06-28 | Traditional | PDF ↗ |
| K181023 | Mozec Rx PTCA Balloon Dilatation Catheter, Mozec NC Rx PTCA Balloon Dilatation Catheter | Meril Life Sciences Private Limited | 2018-05-17 | Special | PDF ↗ |
| K172264 | OTW Takeru PTCA Balloon Dilatation Catheter | KANEKA Corporation | 2018-03-19 | Special | PDF ↗ |
| K173680 | Sapphire II PRO | Orbusneich Medical Trading, Inc. | 2018-03-01 | Traditional | PDF ↗ |
| K173581 | Gallant PTCA Dilatation Catheter | Medinol, Ltd. | 2018-01-25 | Traditional | PDF ↗ |
| K170941 | RX NC Takeru PTCA Balloon Dilatation Catheter | KANEKA Corporation | 2017-07-07 | Traditional | PDF ↗ |
| K162625 | SeQuent Neo Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheters | B. Braun Interventional Systems, Inc. | 2017-06-12 | Traditional | PDF ↗ |
| K163372 | RX Takeru Balloon Dilatation Catheter | KANEKA Corporation | 2017-04-07 | Traditional | PDF ↗ |
| K163660 | Pantera LEO | Biotronik, Inc. | 2017-01-26 | Special | PDF ↗ |
| K162434 | NC Gallant PTCA Catheter | Medinol, Ltd. | 2017-01-19 | Traditional | PDF ↗ |
| K163114 | Sapphire II PRO | Orbusneich Medical, Inc. | 2017-01-05 | Traditional | PDF ↗ |
| K163174 | Emerge PTCA Dilatation Catheter | Boston Scientific Corporation | 2016-12-14 | Special | PDF ↗ |
| K163200 | Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Cathete | Boston Scientific Corporation | 2016-12-14 | Special | PDF ↗ |
| K160985 | Pantera Pro | Biotronik, Inc. | 2016-10-07 | Traditional | PDF ↗ |
| K162209 | Sapphire NC Plus | Orbusneich Medical, Inc. | 2016-10-06 | Special | PDF ↗ |
| K153742 | Apollo Balloon Dilatation Catheter | Brosmed Medical Co., Ltd. | 2016-08-08 | Traditional | PDF ↗ |
| K160961 | Mozec NC-Rx PTCA Baloon Dilatation Catheter | Meril Life Sciences Private Limited | 2016-07-30 | Traditional | PDF ↗ |
| K160823 | NC Quantum Apex PTCA Dilatation Catheter | Boston Scientific Corporation | 2016-06-23 | Special | PDF ↗ |
| K153682 | Chocolate XD PTCA Balloon Catheter | Trireme Medical, LLC | 2016-06-23 | Traditional | PDF ↗ |
| 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 135cm | Ostial Corporation | 2016-02-16 | Traditional | PDF ↗ |
| K141933 | FILAO NC RX PTCA DILATATION CATHETER | Natec Medical , Ltd. | 2015-06-28 | Traditional | PDF ↗ |
| K150292 | Chocolate PTCA Balloon Catheter | Trireme Medical, LLC | 2015-04-09 | Traditional | PDF ↗ |
| K143480 | Euphora Rapid Exchange Balloon Dilatation Catheter | Medtronic, Inc. | 2015-04-02 | Traditional | PDF ↗ |
| K143160 | FOXTROT NC PTCA Balloon Catheter | Shanghai MicroPort Medical (Group) Co., Ltd. | 2015-03-05 | Traditional | PDF ↗ |
| K133852 | APOLLO BALLOON DILATATION CATHETER | Brosmed Medical | 2014-09-19 | Traditional | PDF ↗ |
| K141025 | ARTIMES BALLOON DILATATION CATHETER | Brosmed Medical | 2014-09-12 | Traditional | PDF ↗ |
| K141090 | NC EUPHORA RAPID EXCHANGE BALLOON DILATATION CATHETER | Medtronic, Inc. | 2014-08-15 | Traditional | PDF ↗ |
| K141236 | NC EMERGE PTCA DILATATION CATHETER (MONORAIL), NC EMERGE PTCA DILATATION CATHETER (OVER-THE-WIRE) | Boston Scientific Corporation | 2014-08-07 | Traditional | PDF ↗ |
| K134031 | THREADER MONORAIL MICRO-DILATATION CATHETER, THREADER OVER-THE-WIRE MICRO-DILATATION CATHETER | Boston Scientific Corporation | 2014-07-21 | Traditional | PDF ↗ |
| K133633 | CHOCOLATE PTCA BOLLOON CATHETER | Trireme Medical, Inc. | 2014-06-02 | Traditional | PDF ↗ |
| K131169 | MOZEC - RX PTCA BALLOON DILATATION CATHETER | Meril Life Sciences Private Limited | 2013-12-24 | Traditional | PDF ↗ |
| K123473 | HOPER PTCA BALLOON CATHETER | Lepu Medical Technology (Beijing) Co., Ltd. | 2013-08-13 | Traditional | PDF ↗ |
| K131450 | FLASH MINI OSTIAL SYSTEM - 3.0MM X 135CM, FLASH MINI OSTIAL SYSTEM - 3.5MM X 8MM X 135CM, FLASH MINI OSTIAL SYSTEM - 4.0 | Ostial Corporation | 2013-08-06 | Special | PDF ↗ |
| K130391 | EMERGE MONORAIL PTCA DILATATION CATHETER, EMERGE PUSH MONORAIL PTCA DILATATION CATHETER, EMERGE OVER-THE-WIRE PTCA DILAT | Boston Scientific Corp | 2013-07-10 | Traditional | PDF ↗ |
| K123279 | MINI TREK RX CORONARY DILATATION CATHETER (INCLUDING 1.20 MM SIZE), MINI TREK OTW CORONARY DILATATION CATHETER (INCLUDIN | Abbott Vascular | 2013-01-30 | Traditional | PDF ↗ |
| K123264 | DK-PTCA BALLOON CATHETER | Intuit Medical, LLC | 2013-01-16 | Traditional | PDF ↗ |
| K112735 | TAMARIN BLUE PTCA RX DILATATION CATHETER | Natec Medical , Ltd. | 2012-11-02 | Traditional | PDF ↗ |
| K122178 | FLASH-C PTCA BALLOON DILATATION CATHETER - 4MM X 14MM X 135CM, FLASH-C PTCA BALLOON DILATATION CATHETER - 4MM X 19MM X 1 | Ostial Corporation | 2012-10-11 | Traditional | PDF ↗ |
| K121196 | EMERGE PTCA DILATATION CATHETER (MONORAIL) EMERGE PTCA DILATATION CATHETER (OVER-THE-WIRE) | Boston Scientific Corp | 2012-08-31 | Traditional | PDF ↗ |
| K121667 | NC QUANTUM APEX PTCA DILATATION CATHETER (MONORAIL) | Boston Scientific Corp | 2012-08-13 | Special | PDF ↗ |
| 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 19MM | Ostial Corporation | 2012-06-29 | Special | PDF ↗ |
| K121681 | GLIDER PTCA BALLOON CATHETER | Trireme Medical, Inc. | 2012-06-26 | Special | PDF ↗ |
| K121222 | TREK OTW CORONARY DILATATION CATHETER MINI TREK OTW CORONARY DILATATION CATHETER | Abbott Vascular | 2012-06-22 | Special | PDF ↗ |
| K113220 | EMERGE PTCA DILATATION CATHETER (MONORAIL) EMERGE PTCA DILATATION CATHETER (OVER-THE-WIRE) | Boston Scientific Corporation | 2012-03-22 | Traditional | PDF ↗ |
| K113464 | NC TREK OTW CORONARY DILATATION CATHETER | Abbott Vascular | 2012-03-06 | Traditional | PDF ↗ |
| K111544 | GLIDER PTCA BALLOON CATHETER | Trireme Medical, Inc. | 2012-03-02 | Traditional | PDF ↗ |
| K103808 | SAPPHIRE NC | Orbusneich Medical, Inc. | 2011-09-01 | Traditional | PDF ↗ |
| K111284 | FLASH-C PTCA BALLOON DILATION CATHETER - 5MM X 19MM X 135CM / 6MM X 19MM X 135CM | Ostial Corporation | 2011-08-17 | Traditional | PDF ↗ |
| K103657 | SAPPHIRE | Orbusneich Medical, Inc. | 2011-08-09 | Traditional | PDF ↗ |
| K110133 | EMPIRA RX PTCA DILATATION CATHETER, EMPRIA NC RX PTCA DILATATION CATHETER | Creganna-Tactx Medical | 2011-06-10 | Traditional | PDF ↗ |
| K110617 | MINI TREK RX 1.20 MM CORONARY DILATATION CATHETER, MINI TREK OTW 1.20 MM CORONARY DILATATION CATHETER | Abbott Vascular | 2011-06-02 | Traditional | PDF ↗ |
| K110134 | NC TREK RX CORONARY DILATATION CATHETER | Abbott Vascular-Cardiac Therapies | 2011-02-11 | Special | PDF ↗ |
| K103110 | MINI TREK(TM) RX AND TREK(TM) RX CORONARY DILATATION CATHETER MINI TREK(TM) OTW AND TREK(TM) OTW DILATATION CATHETER | Abbott Vascular-Cardiac Therapies | 2011-01-10 | Traditional | PDF ↗ |
| K103153 | VOYAGER NC CORONARY DILATATION CATHETER AND NC TREK RX CORONARY DILATATION CATHETER | Abbott Vascular-Cardiac Therapies | 2010-12-30 | Traditional | PDF ↗ |
| K103095 | SPRINTER LEGEND 1.25MM RX AND SPRINTER LEGEND 1.25MM OTW BALLOON | Medtronic, Ireland | 2010-10-22 | Traditional | PDF ↗ |
| K896108 | THE PILOT SCIMED TORQUE DEVICE | Scimed Life Systems, Inc. | 1990-01-09 | Traditional | PDF ↗ |
| K861847 | ACS ROTATING HEMO VALVE - DUAL ACCESS TYPE | Advanced Cardiovascular Systems, Inc. | 1986-06-16 | Traditional | PDF ↗ |
| K843944 | PTCA BALLOON CATHETERS & ACCESSORIES | Advanced Cardiovascular Systems, Inc. | 1985-02-14 | Traditional | PDF ↗ |
| K820410 | HEMOTEC HEPCON/SYSTEM FOUR & FOUR P | Hemotec, Inc. | 1982-04-09 | Traditional | PDF ↗ |
Product code LOX · Class II · Cardiovascular. Data: openFDA.