LOX — Catheters, Transluminal Coronary Angioplasty, Percutaneous Class II
FDA product code LOX covers "Catheters, Transluminal Coronary Angioplasty, Percutaneous", a Class II medical device regulated under 21 CFR 870.5100. Submissions are reviewed by the Cardiovascular panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LOX
- Device Class
- Class II
- Regulation Number
- 870.5100
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K252116 | shanghai microport medical (group) co | Firefighter Pro PTCA Balloon Catheter | April 7, 2026 |
| K254022 | verge medical | FLASH Flex Aorto-Ostial Angioplasty System | April 2, 2026 |
| K252295 | terumo corporation | Ryurei | March 27, 2026 |
| K251970 | medtronic, ireland | Sprinter Legend Rapid Exchange Balloon Dilatation Catheter | January 17, 2026 |
| K242969 | biotronik | Pantera Pro; Pantera LEO | October 25, 2024 |
| K233499 | orbusneich medical (shenzhen) co | Sapphire NC ULTRA Coronary Dilatation Catheter | August 16, 2024 |
| K233505 | orbusneich medical (shenzhen) co | Sapphire ULTRA Coronary Dilatation Catheter | August 15, 2024 |
| K233729 | vascular solutions | Ringer perfusion balloon catheter, 2.00 x 20mm (5881); Ringer perfusion balloon | May 31, 2024 |
| K223189 | shanghai microport medical (group) co | Firefighter NC Pro PTCA Balloon Catheter | July 21, 2023 |
| K230374 | dongguan tt medical | Coronary Dilatation Balloon Catheter (VesPenetrator®), Coronary Dilatation Ballo | June 29, 2023 |
| K230705 | brosmed medical co | POT PTCA Balloon Dilatation Catheter | April 11, 2023 |
| K223022 | sino medical sciences technology | SC HONKYTONK PTCA Balloon Dilatation Catheter | February 15, 2023 |
| K222538 | sino medical sciences technology | NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter | December 21, 2022 |
| K220634 | abbott vascular | NC TREK NEO Coronary Dilatation Catheter | June 30, 2022 |
| K220629 | boston scientific | Emerge Monorail PTCA Dilatation Catheter | March 24, 2022 |
| K212393 | sis medical | OPN NC PTCA Dilatation Catheter | March 14, 2022 |
| K211349 | kossel medtech (suzhou) co | Selebrek PTCA Balloon Dilatation Catheter | January 7, 2022 |
| K211807 | orbusneich medical (shenzhen) co | Sapphire NC 24 | October 14, 2021 |
| K210012 | natec medical | Tamarin Blue PTCA RX Dilatation Catheter | July 9, 2021 |
| K211393 | kossel medtech (suzhou) co | Selethru(TM) NC PTCA Balloon Dilatation Catheter | July 2, 2021 |