Product Code: LOX
FDA class 2
21 CFR 870.5100
Catheters, Transluminal Coronary Angioplasty, Percutaneous
Cardiovascular
Percutaneous transluminal coronary angioplasty (PTCA) catheters are used to dilate narrowed or blocked coronary arteries by advancing a balloon-tipped catheter to the site of obstruction and inflating the balloon under hydraulic pressure. According to its definition, a PTCA catheter operates on the principle of hydraulic pressurization applied through an inflatable balloon attached to the distal end of the catheter. It is classified as a Class 2 (moderate risk) device, subject to general controls and special controls, and requires 510(k) premarket notification before marketing. The product code is LOX, regulated under 21 CFR 870.5100, within the Cardiovascular medical specialty.
510(k)s
86
FEI Numbers
76
Registration Numbers
76
Unique Applicants
36
Years Active
44
Research product code LOX in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- LOX
- Device Class
- FDA class 2
- Regulation Number
- 870.5100
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
Definition
A PTCA catheter is a device that operates on the principle of hydraulic pressurization applied through an inflatable balloon attached to the distal end.
510(k) Clearance History
Loading...
Related 510(k) Clearances
This FDA classification is associated with 86 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K252116 | Firefighter Pro PTCA Balloon Catheter | Apr 07, 2026 | Substantially Equivalent | Shanghai MicroPort Medical (Group) Co., Ltd. |
| K254022 | FLASH Flex Aorto-Ostial Angioplasty System | Apr 02, 2026 | Substantially Equivalent | Verge Medical, Inc. |
| K252295 | Ryurei | Mar 27, 2026 | Substantially Equivalent | Terumo Corporation |
| K251970 | Sprinter Legend Rapid Exchange Balloon Dilatation Catheter | Jan 17, 2026 | Substantially Equivalent | Medtronic, Ireland |
| K242969 | Pantera Pro; Pantera LEO | Oct 25, 2024 | Substantially Equivalent | Biotronik, Inc. |
| K233499 | Sapphire NC ULTRA Coronary Dilatation Catheter | Aug 16, 2024 | Substantially Equivalent | OrbusNeich Medical (Shenzhen) Co., Ltd. |
| K233505 | Sapphire ULTRA Coronary Dilatation Catheter | Aug 15, 2024 | Substantially Equivalent | OrbusNeich Medical (Shenzhen) Co., Ltd. |
| 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 | May 31, 2024 | Substantially Equivalent | Vascular Solutions, LLC |
| K223189 | Firefighter NC Pro PTCA Balloon Catheter | Jul 21, 2023 | Substantially Equivalent | Shanghai MicroPort Medical (Group) Co., Ltd. |
| K230374 | Coronary Dilatation Balloon Catheter (VesPenetrator®), Coronary Dilatation Balloon Catheter (VesTraveler®), Coronary Dilatation Balloon Catheter (VexPander®) | Jun 29, 2023 | Substantially Equivalent | Dongguan TT Medical, Inc. |
| K230705 | POT PTCA Balloon Dilatation Catheter | Apr 11, 2023 | Substantially Equivalent | Brosmed Medical Co., Ltd. |
| K223022 | SC HONKYTONK PTCA Balloon Dilatation Catheter | Feb 15, 2023 | Substantially Equivalent | Sino Medical Sciences Technology, Inc. |
| K222538 | NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter | Dec 21, 2022 | Substantially Equivalent | Sino Medical Sciences Technology, Inc. |
| K220634 | NC TREK NEO Coronary Dilatation Catheter | Jun 30, 2022 | Substantially Equivalent | Abbott Vascular |
| K220629 | Emerge Monorail PTCA Dilatation Catheter | Mar 24, 2022 | Substantially Equivalent | Boston Scientific |
| K212393 | OPN NC PTCA Dilatation Catheter | Mar 14, 2022 | Substantially Equivalent | Sis Medical AG |
| K211349 | Selebrek PTCA Balloon Dilatation Catheter | Jan 07, 2022 | Substantially Equivalent | Kossel Medtech (Suzhou) Co., Ltd. |
| K211807 | Sapphire NC 24 | Oct 14, 2021 | Substantially Equivalent | OrbusNeich Medical (Shenzhen) Co., Ltd. |
| K210012 | Tamarin Blue PTCA RX Dilatation Catheter | Jul 09, 2021 | Substantially Equivalent | Natec Medical , Ltd. |
| K211393 | Selethru(TM) NC PTCA Balloon Dilatation Catheter | Jul 02, 2021 | Substantially Equivalent | Kossel Medtech (Suzhou) Co., Ltd. |
| K202578 | KardiFlex NC Coronary Dilatation Catheter | May 06, 2021 | Substantially Equivalent | Medcaptain Life Science Co., Ltd. |
| K202619 | KardiFlex PTCA Balloon Dilatation Catheter | Apr 29, 2021 | Substantially Equivalent | Medcaptain Life Science Co., Ltd. |
| K203390 | Artimes pro Balloon Dilatation Catheter | Apr 14, 2021 | Substantially Equivalent | Brosmed Medical Co., Ltd. |
| K200269 | Sapphire II PRO | Mar 04, 2020 | Substantially Equivalent | Orbusneich Medical Trading, Inc. |
| K192344 | Sapphire NC Plus Coronary Dilatation Catheter | Sep 19, 2019 | Substantially Equivalent | Orbusneich Medical Trading, Inc. |
| K182699 | Selethru PTCA Balloon Dilatation Catheter | Nov 26, 2018 | Substantially Equivalent | Kossel Medtech (Suzhou) Co., Ltd. |
| 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 | Aug 24, 2018 | Substantially Equivalent | Abbott Vascular |
| K180921 | Sapphire II PRO Balloon Dilatation Catheter | Jun 28, 2018 | Substantially Equivalent | Orbusneich Medical Trading, Inc. |
| K181023 | Mozec Rx PTCA Balloon Dilatation Catheter, Mozec NC Rx PTCA Balloon Dilatation Catheter | May 17, 2018 | Substantially Equivalent | Meril Life Sciences Private Limited |
| K172264 | OTW Takeru PTCA Balloon Dilatation Catheter | Mar 19, 2018 | Substantially Equivalent | KANEKA Corporation |
| K173680 | Sapphire II PRO | Mar 01, 2018 | Substantially Equivalent | Orbusneich Medical Trading, Inc. |
| K173581 | Gallant PTCA Dilatation Catheter | Jan 25, 2018 | Substantially Equivalent | Medinol, Ltd. |
| K170941 | RX NC Takeru PTCA Balloon Dilatation Catheter | Jul 07, 2017 | Substantially Equivalent | KANEKA Corporation |
| K162625 | SeQuent Neo Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheters | Jun 12, 2017 | Substantially Equivalent | B. Braun Interventional Systems, Inc. |
| K163372 | RX Takeru Balloon Dilatation Catheter | Apr 07, 2017 | Substantially Equivalent | KANEKA Corporation |
| K163660 | Pantera LEO | Jan 26, 2017 | Substantially Equivalent | Biotronik, Inc. |
| K162434 | NC Gallant PTCA Catheter | Jan 19, 2017 | Substantially Equivalent | Medinol, Ltd. |
| K163114 | Sapphire II PRO | Jan 05, 2017 | Substantially Equivalent | Orbusneich Medical, Inc. |
| K163200 | Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Cathete | Dec 14, 2016 | Substantially Equivalent | Boston Scientific Corporation |
| K163174 | Emerge PTCA Dilatation Catheter | Dec 14, 2016 | Substantially Equivalent | Boston Scientific Corporation |
| K160985 | Pantera Pro | Oct 07, 2016 | Substantially Equivalent | Biotronik, Inc. |
| K162209 | Sapphire NC Plus | Oct 06, 2016 | Substantially Equivalent | Orbusneich Medical, Inc. |
| K153742 | Apollo Balloon Dilatation Catheter | Aug 08, 2016 | Substantially Equivalent | Brosmed Medical Co., Ltd. |
| K160961 | Mozec NC-Rx PTCA Baloon Dilatation Catheter | Jul 30, 2016 | Substantially Equivalent | Meril Life Sciences Private Limited |
| K160823 | NC Quantum Apex PTCA Dilatation Catheter | Jun 23, 2016 | Substantially Equivalent | Boston Scientific Corporation |
| K153682 | Chocolate XD PTCA Balloon Catheter | Jun 23, 2016 | Substantially Equivalent | Trireme Medical, LLC |
| 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 | Feb 16, 2016 | Substantially Equivalent | Ostial Corporation |
| K141933 | FILAO NC RX PTCA DILATATION CATHETER | Jun 28, 2015 | Substantially Equivalent | Natec Medical , Ltd. |
| K150292 | Chocolate PTCA Balloon Catheter | Apr 09, 2015 | Substantially Equivalent | Trireme Medical, LLC |
| K143480 | Euphora Rapid Exchange Balloon Dilatation Catheter | Apr 02, 2015 | Substantially Equivalent | Medtronic, Inc. |
| K143160 | FOXTROT NC PTCA Balloon Catheter | Mar 05, 2015 | Substantially Equivalent | Shanghai MicroPort Medical (Group) Co., Ltd. |
| K133852 | APOLLO BALLOON DILATATION CATHETER | Sep 19, 2014 | Substantially Equivalent | Brosmed Medical |
| K141025 | ARTIMES BALLOON DILATATION CATHETER | Sep 12, 2014 | Substantially Equivalent | Brosmed Medical |
| K141090 | NC EUPHORA RAPID EXCHANGE BALLOON DILATATION CATHETER | Aug 15, 2014 | Substantially Equivalent | Medtronic, Inc. |
| K141236 | NC EMERGE PTCA DILATATION CATHETER (MONORAIL), NC EMERGE PTCA DILATATION CATHETER (OVER-THE-WIRE) | Aug 07, 2014 | Substantially Equivalent | Boston Scientific Corporation |
| K134031 | THREADER MONORAIL MICRO-DILATATION CATHETER, THREADER OVER-THE-WIRE MICRO-DILATATION CATHETER | Jul 21, 2014 | Substantially Equivalent | Boston Scientific Corporation |
| K133633 | CHOCOLATE PTCA BOLLOON CATHETER | Jun 02, 2014 | Substantially Equivalent | Trireme Medical, Inc. |
| K131169 | MOZEC - RX PTCA BALLOON DILATATION CATHETER | Dec 24, 2013 | Substantially Equivalent | Meril Life Sciences Private Limited |
| K123473 | HOPER PTCA BALLOON CATHETER | Aug 13, 2013 | Substantially Equivalent | Lepu Medical Technology (Beijing) Co., Ltd. |
| 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 | Aug 06, 2013 | Substantially Equivalent | Ostial Corporation |
| K130391 | EMERGE MONORAIL PTCA DILATATION CATHETER, EMERGE PUSH MONORAIL PTCA DILATATION CATHETER, EMERGE OVER-THE-WIRE PTCA DILAT | Jul 10, 2013 | Substantially Equivalent | Boston Scientific Corp |
| K123279 | MINI TREK RX CORONARY DILATATION CATHETER (INCLUDING 1.20 MM SIZE), MINI TREK OTW CORONARY DILATATION CATHETER (INCLUDIN | Jan 30, 2013 | Substantially Equivalent | Abbott Vascular |
| K123264 | DK-PTCA BALLOON CATHETER | Jan 16, 2013 | Substantially Equivalent | Intuit Medical, LLC |
| K112735 | TAMARIN BLUE PTCA RX DILATATION CATHETER | Nov 02, 2012 | Substantially Equivalent | Natec Medical , Ltd. |
| K122178 | FLASH-C PTCA BALLOON DILATATION CATHETER - 4MM X 14MM X 135CM, FLASH-C PTCA BALLOON DILATATION CATHETER - 4MM X 19MM X 1 | Oct 11, 2012 | Substantially Equivalent | Ostial Corporation |
| K121196 | EMERGE PTCA DILATATION CATHETER (MONORAIL) EMERGE PTCA DILATATION CATHETER (OVER-THE-WIRE) | Aug 31, 2012 | Substantially Equivalent | Boston Scientific Corp |
| K121667 | NC QUANTUM APEX PTCA DILATATION CATHETER (MONORAIL) | Aug 13, 2012 | Substantially Equivalent | Boston Scientific Corp |
| 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 | Jun 29, 2012 | Substantially Equivalent | Ostial Corporation |
| K121681 | GLIDER PTCA BALLOON CATHETER | Jun 26, 2012 | Substantially Equivalent | Trireme Medical, Inc. |
| K121222 | TREK OTW CORONARY DILATATION CATHETER MINI TREK OTW CORONARY DILATATION CATHETER | Jun 22, 2012 | Substantially Equivalent | Abbott Vascular |
| K113220 | EMERGE PTCA DILATATION CATHETER (MONORAIL) EMERGE PTCA DILATATION CATHETER (OVER-THE-WIRE) | Mar 22, 2012 | Substantially Equivalent | Boston Scientific Corporation |
| K113464 | NC TREK OTW CORONARY DILATATION CATHETER | Mar 06, 2012 | Substantially Equivalent | Abbott Vascular |
| K111544 | GLIDER PTCA BALLOON CATHETER | Mar 02, 2012 | Substantially Equivalent | Trireme Medical, Inc. |
| K103808 | SAPPHIRE NC | Sep 01, 2011 | Substantially Equivalent | Orbusneich Medical, Inc. |
| K111284 | FLASH-C PTCA BALLOON DILATION CATHETER - 5MM X 19MM X 135CM / 6MM X 19MM X 135CM | Aug 17, 2011 | Substantially Equivalent | Ostial Corporation |
| K103657 | SAPPHIRE | Aug 09, 2011 | Substantially Equivalent | Orbusneich Medical, Inc. |
| K110133 | EMPIRA RX PTCA DILATATION CATHETER, EMPRIA NC RX PTCA DILATATION CATHETER | Jun 10, 2011 | Substantially Equivalent | Creganna-Tactx Medical |
| K110617 | MINI TREK RX 1.20 MM CORONARY DILATATION CATHETER, MINI TREK OTW 1.20 MM CORONARY DILATATION CATHETER | Jun 02, 2011 | Substantially Equivalent | Abbott Vascular |
| K110134 | NC TREK RX CORONARY DILATATION CATHETER | Feb 11, 2011 | Substantially Equivalent | Abbott Vascular-Cardiac Therapies |
| K103110 | MINI TREK(TM) RX AND TREK(TM) RX CORONARY DILATATION CATHETER MINI TREK(TM) OTW AND TREK(TM) OTW DILATATION CATHETER | Jan 10, 2011 | Substantially Equivalent | Abbott Vascular-Cardiac Therapies |
| K103153 | VOYAGER NC CORONARY DILATATION CATHETER AND NC TREK RX CORONARY DILATATION CATHETER | Dec 30, 2010 | Substantially Equivalent | Abbott Vascular-Cardiac Therapies |
| K103095 | SPRINTER LEGEND 1.25MM RX AND SPRINTER LEGEND 1.25MM OTW BALLOON | Oct 22, 2010 | Substantially Equivalent | Medtronic, Ireland |
| K896108 | THE PILOT SCIMED TORQUE DEVICE | Jan 09, 1990 | Substantially Equivalent | Scimed Life Systems, Inc. |
| K861847 | ACS ROTATING HEMO VALVE - DUAL ACCESS TYPE | Jun 16, 1986 | Substantially Equivalent | Advanced Cardiovascular Systems, Inc. |
| K843944 | PTCA BALLOON CATHETERS & ACCESSORIES | Feb 14, 1985 | Substantially Equivalent | Advanced Cardiovascular Systems, Inc. |
| K820410 | HEMOTEC HEPCON/SYSTEM FOUR & FOUR P | Apr 09, 1982 | Substantially Equivalent | Hemotec, Inc. |
FEI Numbers
This FDA classification entry is associated with 76 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 76 registration numbers. Click on an entry to view related FDA registrations.