LIT · Catheter, Angioplasty, Peripheral, Transluminal
Cardiovascular · 21 CFR 870.1250 · Class 2
Overview
| Product Code | LIT |
|---|---|
| Device Name | Catheter, Angioplasty, Peripheral, Transluminal |
| Regulation | 21 CFR 870.1250 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| 3rd-Party Reviewable | Yes |
Identification
A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 402)
Showing 20 most recent of 402 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252512 | Armada 14 NC PTA Catheter | ABBOTT MEDICAL | Feb 13, 2026 | SESE |
| K251915 | Amethyst HP PTA OTW 0.035 Catheter | Natec Medical , Ltd. | Dec 18, 2025 | SESE |
| K250706 | Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters; Passeo-14 Peripheral Dilatation Catheter; Oscar Peripheral Multifunctional Catheter System; Pantera Pro Percutaneous Transluminal Coronary Angioplasty Catheter; Pantera LEO Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter | Biotronik, Inc. | Apr 4, 2025 | SESE |
| K243704 | Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon Dilatation Catheter; Parafleet SC 035 PTA Balloon Dilatation Catheter | Brosmed Medical Co., Ltd. | Feb 27, 2025 | SESE |
| K241040 | Amethyst HP PTA OTW 0.035 Catheter | Natec Medical , Ltd. | Dec 18, 2024 | SESE |
| K242419 | 018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter | Creagh Medical Ltd. Dba Surmodics, Inc. | Nov 15, 2024 | SESE |
| K241740 | Finesse Injectable PTA Balloon Dilatation Catheter | Summa Therapeutics | Jul 16, 2024 | SESE |
| K241711 | Oscar Peripheral Multifunctional Catheter system | Biotronik, Inc. | Jul 11, 2024 | SESE |
| K241683 | Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031404020 ); Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031406020); Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031408020); Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031410020); Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031412020); Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031415020); Sterling MONORAIL PTA Balloon Dilatation Catheter (H749390314 | Boston Scientific Corporation | Jul 10, 2024 | SESE |
| K241025 | JADE PLUS PTA Balloon Dilatation Catheter | OrbusNeich Medical (Shenzhen) Co., Ltd. | Jun 11, 2024 | SESE |
| K231402 | HP PTA Balloon Dilatation Catheter | Kossel Medtech (Suzhou) Co., Ltd. | Dec 20, 2023 | SESE |
| K230263 | Finesse Injectable PTA Balloon Dilatation Catheter | Summa Therapeutics, LLC | May 26, 2023 | SESE |
| K214009 | D·Kaptain PTA High Pressure Balloon Dilatation Catheter | Dk Medical Technology Co., Ltd. | Apr 5, 2023 | SESE |
| K230191 | Arise UHP Dilatation Catheter | Creagh Medical, Ltd. | Mar 22, 2023 | SESE |
| K222065 | Passeo-35 Xeo Peripheral Dilatation Catheter | Biotronik, Inc. | Feb 16, 2023 | SESE |
| K223177 | Highlander 014 PTA Balloon Dilatation Catheter | C.R. Bard, Inc. | Jan 20, 2023 | SESE |
| K221245 | PTA Balloon Dilatation Catheter | Kossel Medtech (Suzhou) Co., Ltd. | Dec 14, 2022 | SESE |
| K221414 | ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter | Silk Road Medical, Inc. | Sep 2, 2022 | SESE |
| K221832 | SABER .014 PTA Dilatation Catheter; SABERX .014 PTA Dilatation Catheter | Cordis US Corp | Aug 22, 2022 | SESE |
| K212215 | Tiche PTA Balloon Dilatation Catheter | Brosmed Medical Co., Ltd. | Jul 19, 2022 | SESE |
Top Applicants
- Boston Scientific Corp — 38 clearances
- Cordis Corp. — 25 clearances
- Meadox Medicals, Div. Boston Scientific Corp. — 14 clearances
- Vas-Cath, Inc. — 14 clearances
- C.R. Bard, Inc. — 13 clearances
