Panels › Cardiovascular › Product code LOX · Class 2
Catheters, Transluminal Coronary Angioplasty, Percutaneous
Regulation 870.5100
6510(k)s in 12 months (88 all time)
0recalls in 12 months (121 all time)
29recalls that name a 510(k)
Top companies in LOX
| Company | 510(k)s | Recalls |
|---|---|---|
| Cordis Corporation | 0 | 83 |
| Abbott Vascular | 6 | 20 |
| Boston Scientific | 10 | 6 |
| Brosmed Medical | 5 | 0 |
| Ostial Corporation | 5 | 0 |
| Trireme Medical, Inc. | 5 | 0 |
| Medtronic, Inc. | 2 | 2 |
| Medtronic Ireland | 4 | 0 |
| Medtronic Vascular Galway DBA Medtronic Ireland | 0 | 4 |
| Orbusneich Medical, Inc. | 4 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 9, 2015 | K150292 | Chocolate PTCA Balloon Catheter Trireme Medical, LLC | LOX |
| Apr 2, 2015 | K143480 | Euphora Rapid Exchange Balloon Dilatation Catheter Medtronic, Inc., IE | LOX |
| Mar 5, 2015 | K143160 | FOXTROT NC PTCA Balloon Catheter Shanghai MicroPort Medical (Group) Co., Ltd., CN | LOX |
| Sep 19, 2014 | K133852 | APOLLO BALLOON DILATATION CATHETER Brosmed Medical, CN | LOX |
| Sep 12, 2014 | K141025 | ARTIMES BALLOON DILATATION CATHETER Brosmed Medical, CN | LOX |
| Aug 15, 2014 | K141090 | NC EUPHORA RAPID EXCHANGE BALLOON DILATATION CATHETER Medtronic, Inc., IE | LOX |
| Aug 7, 2014 | K141236 | NC EMERGE PTCA DILATATION CATHETER (MONORAIL), NC EMERGE PTCA DILATATION CATHETER (OVER-THE-WIRE) Boston Scientific Corporation | LOX |
| Jul 21, 2014 | K134031 | THREADER MONORAIL MICRO-DILATATION CATHETER, THREADER OVER-THE-WIRE MICRO-DILATATION CATHETER Boston Scientific Corporation | LOX |
| Jun 2, 2014 | K133633 | CHOCOLATE PTCA BOLLOON CATHETER Trireme Medical, Inc. | LOX |
| Dec 24, 2013 | K131169 | MOZEC - RX PTCA BALLOON DILATATION CATHETER Meril Life Sciences Private Limited | LOX |
| Aug 13, 2013 | K123473 | HOPER PTCA BALLOON CATHETER Lepu Medical Technology (Beijing) Co., Ltd. | LOX |
| Aug 6, 2013 | 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 | LOX |
| Jul 10, 2013 | K130391 | EMERGE MONORAIL PTCA DILATATION CATHETER, EMERGE PUSH MONORAIL PTCA DILATATION CATHETER, EMERGE OVER-THE-WIRE PTCA DILAT Boston Scientific Corp | LOX |
| Jan 30, 2013 | K123279 | MINI TREK RX CORONARY DILATATION CATHETER (INCLUDING 1.20 MM SIZE), MINI TREK OTW CORONARY DILATATION CATHETER (INCLUDIN Abbott Vascular | LOX |
| Jan 16, 2013 | K123264 | DK-PTCA BALLOON CATHETER Intuit Medical, LLC | LOX |
| Nov 2, 2012 | K112735 | TAMARIN BLUE PTCA RX DILATATION CATHETER Natec Medical , Ltd. | LOX |
| Oct 11, 2012 | 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 | LOX |
| Aug 31, 2012 | K121196 | EMERGE PTCA DILATATION CATHETER (MONORAIL) EMERGE PTCA DILATATION CATHETER (OVER-THE-WIRE) Boston Scientific Corp | LOX |
| Aug 13, 2012 | K121667 | NC QUANTUM APEX PTCA DILATATION CATHETER (MONORAIL) Boston Scientific Corp | LOX |
| Jun 29, 2012 | 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 | LOX |
| Jun 26, 2012 | K121681 | GLIDER PTCA BALLOON CATHETER Trireme Medical, Inc. | LOX |
| Jun 22, 2012 | K121222 | TREK OTW CORONARY DILATATION CATHETER MINI TREK OTW CORONARY DILATATION CATHETER Abbott Vascular | LOX |
| Mar 22, 2012 | K113220 | EMERGE PTCA DILATATION CATHETER (MONORAIL) EMERGE PTCA DILATATION CATHETER (OVER-THE-WIRE) Boston Scientific Corporation | LOX |
| Mar 6, 2012 | K113464 | NC TREK OTW CORONARY DILATATION CATHETER Abbott Vascular | LOX |
| Mar 2, 2012 | K111544 | GLIDER PTCA BALLOON CATHETER Trireme Medical, Inc. | LOX |
| Sep 1, 2011 | K103808 | SAPPHIRE NC Orbusneich Medical, Inc. | LOX |
| Aug 17, 2011 | K111284 | FLASH-C PTCA BALLOON DILATION CATHETER - 5MM X 19MM X 135CM / 6MM X 19MM X 135CM Ostial Corporation | LOX |
| Aug 9, 2011 | K103657 | SAPPHIRE Orbusneich Medical, Inc. | LOX |
| Jun 10, 2011 | K110133 | EMPIRA RX PTCA DILATATION CATHETER, EMPRIA NC RX PTCA DILATATION CATHETER Creganna-Tactx Medical | LOX |
| Jun 2, 2011 | K110617 | MINI TREK RX 1.20 MM CORONARY DILATATION CATHETER, MINI TREK OTW 1.20 MM CORONARY DILATATION CATHETER Abbott Vascular | LOX |
| Feb 11, 2011 | K110134 | NC TREK RX CORONARY DILATATION CATHETER Abbott Vascular-Cardiac Therapies | LOX |
| Jan 10, 2011 | 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 | LOX |
| Dec 30, 2010 | K103153 | VOYAGER NC CORONARY DILATATION CATHETER AND NC TREK RX CORONARY DILATATION CATHETER Abbott Vascular-Cardiac Therapies | LOX |
| Oct 22, 2010 | K103095 | SPRINTER LEGEND 1.25MM RX AND SPRINTER LEGEND 1.25MM OTW BALLOON Medtronic, Ireland | LOX |
| Jan 9, 1990 | K896108 | THE PILOT SCIMED TORQUE DEVICE Scimed Life Systems, Inc. | LOX |
| Jun 16, 1986 | K861847 | ACS ROTATING HEMO VALVE - DUAL ACCESS TYPE Advanced Cardiovascular Systems, Inc. | LOX |
| Feb 14, 1985 | K843944 | PTCA BALLOON CATHETERS & ACCESSORIES Advanced Cardiovascular Systems, Inc. | LOX |
| Apr 9, 1982 | K820410 | HEMOTEC HEPCON/SYSTEM FOUR & FOUR P Hemotec, Inc. | LOX |
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