LOX — Catheters, Transluminal Coronary Angioplasty, Percutaneous Class II
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 |
|---|---|---|---|
| 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 |
| K202578 | medcaptain life science co | KardiFlex NC Coronary Dilatation Catheter | May 6, 2021 |
| K202619 | medcaptain life science co | KardiFlex PTCA Balloon Dilatation Catheter | April 29, 2021 |
| K203390 | brosmed medical co | Artimes pro Balloon Dilatation Catheter | April 14, 2021 |