LIT — Catheter, Angioplasty, Peripheral, Transluminal Class II
FDA Device Classification
Classification Details
- Product Code
- LIT
- Device Class
- Class II
- Regulation Number
- 870.1250
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K252512 | abbott medical | Armada 14 NC PTA Catheter | February 13, 2026 |
| K251915 | natec medical | Amethyst HP PTA OTW 0.035 Catheter | December 18, 2025 |
| K250706 | biotronik | Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Ca | April 4, 2025 |
| K243704 | brosmed medical co | Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon D | February 27, 2025 |
| K241040 | natec medical | Amethyst HP PTA OTW 0.035 Catheter | December 18, 2024 |
| K242419 | creagh medical ltd. dba surmodics | 018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter | November 15, 2024 |
| K241740 | summa therapeutics | Finesse Injectable PTA Balloon Dilatation Catheter | July 16, 2024 |
| K241711 | biotronik | Oscar Peripheral Multifunctional Catheter system | July 11, 2024 |
| K241683 | boston scientific corporation | Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031404020 ); Sterling | July 10, 2024 |
| K241025 | orbusneich medical (shenzhen) co | JADE PLUS PTA Balloon Dilatation Catheter | June 11, 2024 |
| K231402 | kossel medtech (suzhou) co | HP PTA Balloon Dilatation Catheter | December 20, 2023 |
| K230263 | summa therapeutics | Finesse Injectable PTA Balloon Dilatation Catheter | May 26, 2023 |
| K214009 | dk medical technology co | D·Kaptain PTA High Pressure Balloon Dilatation Catheter | April 5, 2023 |
| K230191 | creagh medical | Arise UHP Dilatation Catheter | March 22, 2023 |
| K222065 | biotronik | Passeo-35 Xeo Peripheral Dilatation Catheter | February 16, 2023 |
| K223177 | c.r. bard | Highlander 014 PTA Balloon Dilatation Catheter | January 20, 2023 |
| K221245 | kossel medtech (suzhou) co | PTA Balloon Dilatation Catheter | December 14, 2022 |
| K221414 | silk road medical | ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter | September 2, 2022 |
| K221832 | cordis us | SABER .014 PTA Dilatation Catheter; SABERX .014 PTA Dilatation Catheter | August 22, 2022 |
| K212215 | brosmed medical co | Tiche PTA Balloon Dilatation Catheter | July 19, 2022 |