FDA 510(k) Applications for Medical Device Product Code "LOX"
(Catheters, Transluminal Coronary Angioplasty, Percutaneous)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K110617 | Abbott Vascular | MINI TREK RX 1.20 MM CORONARY DILATATION CATHETER, MINI TREK OTW 1.20 MM CORONARY DILATATION CATHETER | 06/02/2011 |
| K123279 | Abbott Vascular | MINI TREK RX CORONARY DILATATION CATHETER (INCLUDING 1.20 MM SIZE), MINI TREK OTW CORONARY DILATATION CATHETER (INCLUDIN | 01/30/2013 |
| K220634 | Abbott Vascular | NC TREK NEO Coronary Dilatation Catheter | 06/30/2022 |
| K113464 | Abbott Vascular | NC TREK OTW CORONARY DILATATION CATHETER | 03/06/2012 |
| K180040 | Abbott Vascular | NC TREKÖ RX Coronary Dilatation Catheter; NC TREKÖ OTW Coronary Dilatation Catheter; TREKÖ RX Coronary Dilatation Catheter; TREKÖ OTW Coronary Dilatation Catheter; MINI TREKÖ RX Coronary Dilatation Catheter; MINI TREKÖ OTW Coronary Dilatation Catheter; MI | 08/24/2018 |
| K121222 | Abbott Vascular | TREK OTW CORONARY DILATATION CATHETER MINI TREK OTW CORONARY DILATATION CATHETER | 06/22/2012 |
| K103110 | ABBOTT VASCULAR-CARDIAC THERAPIES | MINI TREK(TM) RX AND TREK(TM) RX CORONARY DILATATION CATHETER MINI TREK(TM) OTW AND TREK(TM) OTW DILATATION CATHETER | 01/10/2011 |
| K110134 | ABBOTT VASCULAR-CARDIAC THERAPIES | NC TREK RX CORONARY DILATATION CATHETER | 02/11/2011 |
| K103153 | ABBOTT VASCULAR-CARDIAC THERAPIES | VOYAGER NC CORONARY DILATATION CATHETER AND NC TREK RX CORONARY DILATATION CATHETER | 12/30/2010 |
| K162625 | B. BRAUN INTERVENTIONAL SYSTEMS INC. | SeQuent Neo Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheters | 06/12/2017 |
| K160985 | BIOTRONIK, INC | Pantera Pro | 10/07/2016 |
| K163660 | BIOTRONIK, INC. | Pantera LEO | 01/26/2017 |
| K242969 | Biotronik, Inc. | Pantera Pro; Pantera LEO | 10/25/2024 |
| K220629 | Boston Scientific | Emerge Monorail PTCA Dilatation Catheter | 03/24/2022 |
| K130391 | BOSTON SCIENTIFIC CORP. | EMERGE MONORAIL PTCA DILATATION CATHETER, EMERGE PUSH MONORAIL PTCA DILATATION CATHETER, EMERGE OVER-THE-WIRE PTCA DILAT | 07/10/2013 |
| K121196 | BOSTON SCIENTIFIC CORP. | EMERGE PTCA DILATATION CATHETER (MONORAIL) EMERGE PTCA DILATATION CATHETER (OVER-THE-WIRE) | 08/31/2012 |
| K121667 | BOSTON SCIENTIFIC CORP. | NC QUANTUM APEX PTCA DILATATION CATHETER (MONORAIL) | 08/13/2012 |
| K163174 | Boston Scientific Corporation | Emerge PTCA Dilatation Catheter | 12/14/2016 |
| K113220 | Boston Scientific Corporation | EMERGE PTCA DILATATION CATHETER (MONORAIL) EMERGE PTCA DILATATION CATHETER (OVER-THE-WIRE) | 03/22/2012 |
| K163200 | BOSTON SCIENTIFIC CORPORATION | Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Cathete | 12/14/2016 |
| K141236 | Boston Scientific Corporation | NC EMERGE PTCA DILATATION CATHETER (MONORAIL), NC EMERGE PTCA DILATATION CATHETER (OVER-THE-WIRE) | 08/07/2014 |
| K160823 | BOSTON SCIENTIFIC CORPORATION | NC Quantum Apex PTCA Dilatation Catheter | 06/23/2016 |
| K134031 | Boston Scientific Corporation | THREADER MONORAIL MICRO-DILATATION CATHETER, THREADER OVER-THE-WIRE MICRO-DILATATION CATHETER | 07/21/2014 |
| K133852 | BROSMED MEDICAL | APOLLO BALLOON DILATATION CATHETER | 09/19/2014 |
| K141025 | BROSMED MEDICAL | ARTIMES BALLOON DILATATION CATHETER | 09/12/2014 |
| K153742 | BrosMed Medical Co., Ltd. | Apollo Balloon Dilatation Catheter | 08/08/2016 |
| K203390 | BrosMed Medical Co., Ltd. | Artimes pro Balloon Dilatation Catheter | 04/14/2021 |
| K230705 | BrosMed Medical Co., Ltd. | POT PTCA Balloon Dilatation Catheter | 04/11/2023 |
| K110133 | CREGANNA-TACTX MEDICAL | EMPIRA RX PTCA DILATATION CATHETER, EMPRIA NC RX PTCA DILATATION CATHETER | 06/10/2011 |
| K230374 | Dongguan TT Medical, Inc | Coronary Dilatation Balloon Catheter (VesPenetrator«), Coronary Dilatation Balloon Catheter (VesTraveler«), Coronary Dilatation Balloon Catheter (VexPander«) | 06/29/2023 |
| K123264 | INTUIT MEDICAL, LLC | DK-PTCA BALLOON CATHETER | 01/16/2013 |
| K172264 | Kaneka Corporation | OTW Takeru PTCA Balloon Dilatation Catheter | 03/19/2018 |
| K170941 | Kaneka Corporation | RX NC Takeru PTCA Balloon Dilatation Catheter | 07/07/2017 |
| K163372 | KANEKA CORPORATION | RX Takeru Balloon Dilatation Catheter | 04/07/2017 |
| K211349 | Kossel Medtech (Suzhou) Co., Ltd. | Selebrek PTCA Balloon Dilatation Catheter | 01/07/2022 |
| K182699 | Kossel Medtech (Suzhou) Co., Ltd. | Selethru PTCA Balloon Dilatation Catheter | 11/26/2018 |
| K211393 | Kossel Medtech (Suzhou) Co., Ltd. | Selethru(TM) NC PTCA Balloon Dilatation Catheter | 07/02/2021 |
| K123473 | LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD | HOPER PTCA BALLOON CATHETER | 08/13/2013 |
| K202578 | Medcaptain Life Science Co., Ltd. | KardiFlex NC Coronary Dilatation Catheter | 05/06/2021 |
| K202619 | Medcaptain Life Science Co., Ltd. | KardiFlex PTCA Balloon Dilatation Catheter | 04/29/2021 |
| K162434 | MEDINOL LTD. | NC Gallant PTCA Catheter | 01/19/2017 |
| K173581 | Medinol, Ltd. | Gallant PTCA Dilatation Catheter | 01/25/2018 |
| K143480 | MEDTRONIC INC. | Euphora Rapid Exchange Balloon Dilatation Catheter | 04/02/2015 |
| K141090 | MEDTRONIC INC. | NC EUPHORA RAPID EXCHANGE BALLOON DILATATION CATHETER | 08/15/2014 |
| K103095 | MEDTRONIC IRELAND | SPRINTER LEGEND 1.25MM RX AND SPRINTER LEGEND 1.25MM OTW BALLOON | 10/22/2010 |
| K131169 | MERIL LIFE SCIENCES PRIVATE LIMITED | MOZEC - RX PTCA BALLOON DILATATION CATHETER | 12/24/2013 |
| K160961 | MERIL LIFE SCIENCES PRIVATE LIMITED | Mozec NC-Rx PTCA Baloon Dilatation Catheter | 07/30/2016 |
| K181023 | Meril Life Sciences Private Limited | Mozec û Rx PTCA Balloon Dilatation Catheter, Mozec NC û Rx PTCA Balloon Dilatation Catheter | 05/17/2018 |
| K141933 | NATEC MEDICAL LTD | FILAO NC RX PTCA DILATATION CATHETER | 06/28/2015 |
| K112735 | NATEC MEDICAL LTD | TAMARIN BLUE PTCA RX DILATATION CATHETER | 11/02/2012 |
| K210012 | Natec Medical Ltd. | Tamarin Blue PTCA RX Dilatation Catheter | 07/09/2021 |
| K211807 | OrbusNeich Medical (Shenzhen) Co., Ltd. | Sapphire NC 24 | 10/14/2021 |
| K233499 | OrbusNeich Medical (Shenzhen) Co., Ltd. | Sapphire NC ULTRA Coronary Dilatation Catheter | 08/16/2024 |
| K233505 | OrbusNeich Medical (Shenzhen) Co., Ltd. | Sapphire ULTRA Coronary Dilatation Catheter | 08/15/2024 |
| K163114 | OrbusNeich Medical Inc. | Sapphire II PRO | 01/05/2017 |
| K173680 | OrbusNeich Medical Trading Inc. | Sapphire II PRO | 03/01/2018 |
| K200269 | OrbusNeich Medical Trading Inc. | Sapphire II PRO | 03/04/2020 |
| K180921 | OrbusNeich Medical Trading Inc. | Sapphire II PRO Balloon Dilatation Catheter | 06/28/2018 |
| K192344 | OrbusNeich Medical Trading Inc. | Sapphire NC Plus Coronary Dilatation Catheter | 09/19/2019 |
| K162209 | OrbusNeich Medical, Inc | Sapphire NC Plus | 10/06/2016 |
| K103657 | ORBUSNEICH MEDICAL, INC. | SAPPHIRE | 08/09/2011 |
| K103808 | ORBUSNEICH MEDICAL, INC. | SAPPHIRE NC | 09/01/2011 |
| K131450 | OSTIAL CORPORATION | FLASH MINI OSTIAL SYSTEM - 3.0MM X 135CM, FLASH MINI OSTIAL SYSTEM - 3.5MM X 8MM X 135CM, FLASH MINI OSTIAL SYSTEM - 4.0 | 08/06/2013 |
| K152485 | OSTIAL CORPORATION | 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 | 02/16/2016 |
| K122178 | OSTIAL CORPORATION | FLASH-C PTCA BALLOON DILATATION CATHETER - 4MM X 14MM X 135CM, FLASH-C PTCA BALLOON DILATATION CATHETER - 4MM X 19MM X 1 | 10/11/2012 |
| K113775 | OSTIAL CORPORATION | 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 | 06/29/2012 |
| K111284 | OSTIAL CORPORATION | FLASH-C PTCA BALLOON DILATION CATHETER - 5MM X 19MM X 135CM / 6MM X 19MM X 135CM | 08/17/2011 |
| K143160 | SHANGHAI MICROPORT MEDICAL (GROUP) CO., LTD | FOXTROT NC PTCA Balloon Catheter | 03/05/2015 |
| K223189 | Shanghai MicroPort Medical (Group) Co., Ltd. | FirefighterÖ NC Pro PTCA Balloon Catheter | 07/21/2023 |
| K222538 | Sino Medical Sciences Technology Inc. | NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter | 12/21/2022 |
| K223022 | Sino Medical Sciences Technology Inc. | SC HONKYTONK PTCA Balloon Dilatation Catheter | 02/15/2023 |
| K212393 | SIS Medical AG | OPN NC PTCA Dilatation Catheter | 03/14/2022 |
| K133633 | TRIREME MEDICAL INC | CHOCOLATE PTCA BOLLOON CATHETER | 06/02/2014 |
| K111544 | TRIREME MEDICAL INC | GLIDER PTCA BALLOON CATHETER | 03/02/2012 |
| K121681 | TRIREME MEDICAL, INC. | GLIDER PTCA BALLOON CATHETER | 06/26/2012 |
| K150292 | TRIREME MEDICAL, LLC | Chocolate PTCA Balloon Catheter | 04/09/2015 |
| K153682 | TriReme Medical, LLC | Chocolate XD PTCA Balloon Catheter | 06/23/2016 |
| K233729 | Vascular Solutions LLC | 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, | 05/31/2024 |
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