| Euphora Rapid Exchange (RX) Balloon Dilatation Catheter (K261759) | Medtronic Ireland | 2026-07-27 |
| Firefighter™ Pro PTCA Balloon Catheter (K252116) | Shanghai MicroPort Medical (Group) Co., Ltd. | 2026-04-07 |
| FLASH Flex™ Aorto-Ostial Angioplasty System (K254022) | Verge Medical, Inc. | 2026-04-02 |
| Ryurei (K252295) | Terumo Corporation | 2026-03-27 |
| Sprinter Legend Rapid Exchange Balloon Dilatation Catheter (K251970) | Medtronic, Ireland | 2026-01-17 |
| Pantera Pro; Pantera LEO (K242969) | Biotronik, Inc. | 2024-10-25 |
| Sapphire NC ULTRA Coronary Dilatation Catheter (K233499) | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2024-08-16 |
| Sapphire ULTRA Coronary Dilatation Catheter (K233505) | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2024-08-15 |
| 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 (K233729) | Vascular Solutions, LLC | 2024-05-31 |
| Firefighter™ NC Pro PTCA Balloon Catheter (K223189) | Shanghai MicroPort Medical (Group) Co., Ltd. | 2023-07-21 |
| Coronary Dilatation Balloon Catheter (VesPenetrator®), Coronary Dilatation Balloon Catheter (VesTraveler®), Coronary Dilatation Balloon Catheter (VexPander®) (K230374) | Dongguan TT Medical, Inc. | 2023-06-29 |
| POT PTCA Balloon Dilatation Catheter (K230705) | Brosmed Medical Co., Ltd. | 2023-04-11 |
| SC HONKYTONK PTCA Balloon Dilatation Catheter (K223022) | Sino Medical Sciences Technology, Inc. | 2023-02-15 |
| NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter (K222538) | Sino Medical Sciences Technology, Inc. | 2022-12-21 |
| NC TREK NEO Coronary Dilatation Catheter (K220634) | Abbott Vascular | 2022-06-30 |
| Emerge Monorail PTCA Dilatation Catheter (K220629) | Boston Scientific | 2022-03-24 |
| OPN NC PTCA Dilatation Catheter (K212393) | Sis Medical AG | 2022-03-14 |
| Selebrek PTCA Balloon Dilatation Catheter (K211349) | Kossel Medtech (Suzhou) Co., Ltd. | 2022-01-07 |
| Sapphire NC 24 (K211807) | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2021-10-14 |
| Tamarin Blue PTCA RX Dilatation Catheter (K210012) | Natec Medical , Ltd. | 2021-07-09 |
| Selethru(TM) NC PTCA Balloon Dilatation Catheter (K211393) | Kossel Medtech (Suzhou) Co., Ltd. | 2021-07-02 |
| KardiFlex NC Coronary Dilatation Catheter (K202578) | Medcaptain Life Science Co., Ltd. | 2021-05-06 |
| KardiFlex PTCA Balloon Dilatation Catheter (K202619) | Medcaptain Life Science Co., Ltd. | 2021-04-29 |
| Artimes pro Balloon Dilatation Catheter (K203390) | Brosmed Medical Co., Ltd. | 2021-04-14 |
| Sapphire II PRO (K200269) | Orbusneich Medical Trading, Inc. | 2020-03-04 |
| Sapphire NC Plus Coronary Dilatation Catheter (K192344) | Orbusneich Medical Trading, Inc. | 2019-09-19 |
| Selethru PTCA Balloon Dilatation Catheter (K182699) | Kossel Medtech (Suzhou) Co., Ltd. | 2018-11-26 |
| 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 (K180040) | Abbott Vascular | 2018-08-24 |
| Sapphire II PRO Balloon Dilatation Catheter (K180921) | Orbusneich Medical Trading, Inc. | 2018-06-28 |
| Mozec – Rx PTCA Balloon Dilatation Catheter, Mozec NC – Rx PTCA Balloon Dilatation Catheter (K181023) | Meril Life Sciences Private Limited | 2018-05-17 |
| OTW Takeru PTCA Balloon Dilatation Catheter (K172264) | KANEKA Corporation | 2018-03-19 |
| Sapphire II PRO (K173680) | Orbusneich Medical Trading, Inc. | 2018-03-01 |
| Gallant PTCA Dilatation Catheter (K173581) | Medinol, Ltd. | 2018-01-25 |
| RX NC Takeru PTCA Balloon Dilatation Catheter (K170941) | KANEKA Corporation | 2017-07-07 |
| SeQuent Neo Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheters (K162625) | B. Braun Interventional Systems, Inc. | 2017-06-12 |
| RX Takeru Balloon Dilatation Catheter (K163372) | KANEKA Corporation | 2017-04-07 |
| Pantera LEO (K163660) | Biotronik, Inc. | 2017-01-26 |
| NC Gallant PTCA Catheter (K162434) | Medinol, Ltd. | 2017-01-19 |
| Sapphire II PRO (K163114) | Orbusneich Medical, Inc. | 2017-01-05 |
| Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Cathete (K163200) | Boston Scientific Corporation | 2016-12-14 |
| Emerge PTCA Dilatation Catheter (K163174) | Boston Scientific Corporation | 2016-12-14 |
| Pantera Pro (K160985) | Biotronik, Inc. | 2016-10-07 |
| Sapphire NC Plus (K162209) | Orbusneich Medical, Inc. | 2016-10-06 |
| Apollo Balloon Dilatation Catheter (K153742) | Brosmed Medical Co., Ltd. | 2016-08-08 |
| Mozec NC-Rx PTCA Baloon Dilatation Catheter (K160961) | Meril Life Sciences Private Limited | 2016-07-30 |
| NC Quantum Apex PTCA Dilatation Catheter (K160823) | Boston Scientific Corporation | 2016-06-23 |
| Chocolate XD PTCA Balloon Catheter (K153682) | Trireme Medical, LLC | 2016-06-23 |
| 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 (K152485) | Ostial Corporation | 2016-02-16 |
| FILAO NC RX PTCA DILATATION CATHETER (K141933) | Natec Medical , Ltd. | 2015-06-28 |
| Chocolate PTCA Balloon Catheter (K150292) | Trireme Medical, LLC | 2015-04-09 |
| Euphora Rapid Exchange Balloon Dilatation Catheter (K143480) | Medtronic, Inc. | 2015-04-02 |
| FOXTROT NC PTCA Balloon Catheter (K143160) | Shanghai MicroPort Medical (Group) Co., Ltd. | 2015-03-05 |
| APOLLO BALLOON DILATATION CATHETER (K133852) | Brosmed Medical | 2014-09-19 |
| ARTIMES BALLOON DILATATION CATHETER (K141025) | Brosmed Medical | 2014-09-12 |
| NC EUPHORA RAPID EXCHANGE BALLOON DILATATION CATHETER (K141090) | Medtronic, Inc. | 2014-08-15 |
| NC EMERGE PTCA DILATATION CATHETER (MONORAIL), NC EMERGE PTCA DILATATION CATHETER (OVER-THE-WIRE) (K141236) | Boston Scientific Corporation | 2014-08-07 |
| THREADER MONORAIL MICRO-DILATATION CATHETER, THREADER OVER-THE-WIRE MICRO-DILATATION CATHETER (K134031) | Boston Scientific Corporation | 2014-07-21 |
| CHOCOLATE PTCA BOLLOON CATHETER (K133633) | Trireme Medical, Inc. | 2014-06-02 |
| MOZEC - RX PTCA BALLOON DILATATION CATHETER (K131169) | Meril Life Sciences Private Limited | 2013-12-24 |
| HOPER PTCA BALLOON CATHETER (K123473) | Lepu Medical Technology (Beijing) Co., Ltd. | 2013-08-13 |
| FLASH MINI OSTIAL SYSTEM - 3.0MM X 135CM, FLASH MINI OSTIAL SYSTEM - 3.5MM X 8MM X 135CM, FLASH MINI OSTIAL SYSTEM - 4.0 (K131450) | Ostial Corporation | 2013-08-06 |
| EMERGE MONORAIL PTCA DILATATION CATHETER, EMERGE PUSH MONORAIL PTCA DILATATION CATHETER, EMERGE OVER-THE-WIRE PTCA DILAT (K130391) | Boston Scientific Corp | 2013-07-10 |
| MINI TREK RX CORONARY DILATATION CATHETER (INCLUDING 1.20 MM SIZE), MINI TREK OTW CORONARY DILATATION CATHETER (INCLUDIN (K123279) | Abbott Vascular | 2013-01-30 |
| DK-PTCA BALLOON CATHETER (K123264) | Intuit Medical, LLC | 2013-01-16 |
| TAMARIN BLUE PTCA RX DILATATION CATHETER (K112735) | Natec Medical , Ltd. | 2012-11-02 |
| FLASH-C PTCA BALLOON DILATATION CATHETER - 4MM X 14MM X 135CM, FLASH-C PTCA BALLOON DILATATION CATHETER - 4MM X 19MM X 1 (K122178) | Ostial Corporation | 2012-10-11 |
| EMERGE PTCA DILATATION CATHETER (MONORAIL) EMERGE PTCA DILATATION CATHETER (OVER-THE-WIRE) (K121196) | Boston Scientific Corp | 2012-08-31 |
| NC QUANTUM APEX PTCA DILATATION CATHETER (MONORAIL) (K121667) | Boston Scientific Corp | 2012-08-13 |
| 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 (K113775) | Ostial Corporation | 2012-06-29 |
| GLIDER PTCA BALLOON CATHETER (K121681) | Trireme Medical, Inc. | 2012-06-26 |
| TREK OTW CORONARY DILATATION CATHETER MINI TREK OTW CORONARY DILATATION CATHETER (K121222) | Abbott Vascular | 2012-06-22 |
| EMERGE PTCA DILATATION CATHETER (MONORAIL) EMERGE PTCA DILATATION CATHETER (OVER-THE-WIRE) (K113220) | Boston Scientific Corporation | 2012-03-22 |
| NC TREK OTW CORONARY DILATATION CATHETER (K113464) | Abbott Vascular | 2012-03-06 |
| GLIDER PTCA BALLOON CATHETER (K111544) | Trireme Medical, Inc. | 2012-03-02 |
| SAPPHIRE NC (K103808) | Orbusneich Medical, Inc. | 2011-09-01 |
| FLASH-C PTCA BALLOON DILATION CATHETER - 5MM X 19MM X 135CM / 6MM X 19MM X 135CM (K111284) | Ostial Corporation | 2011-08-17 |
| SAPPHIRE (K103657) | Orbusneich Medical, Inc. | 2011-08-09 |
| EMPIRA RX PTCA DILATATION CATHETER, EMPRIA NC RX PTCA DILATATION CATHETER (K110133) | Creganna-Tactx Medical | 2011-06-10 |
| MINI TREK RX 1.20 MM CORONARY DILATATION CATHETER, MINI TREK OTW 1.20 MM CORONARY DILATATION CATHETER (K110617) | Abbott Vascular | 2011-06-02 |
| NC TREK RX CORONARY DILATATION CATHETER (K110134) | Abbott Vascular-Cardiac Therapies | 2011-02-11 |
| MINI TREK(TM) RX AND TREK(TM) RX CORONARY DILATATION CATHETER MINI TREK(TM) OTW AND TREK(TM) OTW DILATATION CATHETER (K103110) | Abbott Vascular-Cardiac Therapies | 2011-01-10 |
| VOYAGER NC CORONARY DILATATION CATHETER AND NC TREK RX CORONARY DILATATION CATHETER (K103153) | Abbott Vascular-Cardiac Therapies | 2010-12-30 |
| SPRINTER LEGEND 1.25MM RX AND SPRINTER LEGEND 1.25MM OTW BALLOON (K103095) | Medtronic, Ireland | 2010-10-22 |
| THE PILOT SCIMED TORQUE DEVICE (K896108) | Scimed Life Systems, Inc. | 1990-01-09 |
| ACS ROTATING HEMO VALVE - DUAL ACCESS TYPE (K861847) | Advanced Cardiovascular Systems, Inc. | 1986-06-16 |
| PTCA BALLOON CATHETERS & ACCESSORIES (K843944) | Advanced Cardiovascular Systems, Inc. | 1985-02-14 |
| HEMOTEC HEPCON/SYSTEM FOUR & FOUR P (K820410) | Hemotec, Inc. | 1982-04-09 |