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 |
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 |
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 |