LIT
- Product code
- LIT
- Device name
- Catheter, Angioplasty, Peripheral, Transluminal
- Device class
- Class 2
- 21 CFR
- 21 CFR 870.1250
- Medical specialty
- Cardiovascular
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 403
510(k) clearances, last 3 years (12)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K260304 | 2026-05-20 | WAVE Medical AG | WAVE PTA Balloon Catheter | |
| K252512 | 2026-02-13 | ABBOTT MEDICAL | Armada 14 NC PTA Catheter | |
| K251915 | 2025-12-18 | Natec Medical , Ltd. | Amethyst HP PTA OTW 0.035 Catheter | |
| K250706 | 2025-04-04 | Biotronik, Inc. | Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo | |
| K243704 | 2025-02-27 | Brosmed Medical Co., Ltd. | Parafleet SC 014 PTA Balloon Dilatation Catheter; Pa | |
| K241040 | 2024-12-18 | Natec Medical , Ltd. | Amethyst HP PTA OTW 0.035 Catheter | |
| K242419 | 2024-11-15 | Creagh Medical Ltd. Dba Surmodics, Inc | 018 Hydrophilic Coated OTW PTA Balloon Dilatation Ca | |
| K241740 | 2024-07-16 | Summa Therapeutics | Finesse Injectable PTA Balloon Dilatation Catheter | FDA |
| K241711 | 2024-07-11 | Biotronik, Inc. | Oscar Peripheral Multifunctional Catheter system | |
| K241683 | 2024-07-10 | Boston Scientific Corporation | Sterling MONORAIL PTA Balloon Dilatation Catheter | |
| K241025 | 2024-06-11 | OrbusNeich Medical (Shenzhen) Co., Ltd | JADE PLUS PTA Balloon Dilatation Catheter | |
| K231402 | 2023-12-20 | Kossel Medtech (Suzhou) Co., Ltd. | HP PTA Balloon Dilatation Catheter | FDA |
Official FDA classification page: LIT
Classification and pathway per current FDA publications. Data from openFDA (CC0).