LIT — Catheter, Angioplasty, Peripheral, Transluminal Class II
FDA product code LIT covers "Catheter, Angioplasty, Peripheral, Transluminal", a Class II medical device regulated under 21 CFR 870.1250. 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
- 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 |
|---|---|---|---|
| K260304 | wave medical | WAVE PTA Balloon Catheter | May 20, 2026 |
| 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 |