Product code LIT
- Device name
- Catheter, Angioplasty, Peripheral, Transluminal
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.1250
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P950020S010 | FLEXTOME CUTTING BALLOON MONORAIL(MR)/OVER THE WIRE(OTW) | Boston Scientific Corp | 2005-07-18 |
| P950020S012 | ULTRA2 CUTTING BALLOON MONORAIL(MR) | Boston Scientific Corp | 2005-03-16 |
| P950020S011 | CUTTING BALLOON MONORAIL(MR)/OVER THE WIRE(OTW) | Boston Scientific Corp | 2005-03-08 |
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260304 | WAVE PTA Balloon Catheter | WAVE Medical AG | 2026-05-20 |
| K252512 | Armada™ 14 NC PTA Catheter | ABBOTT MEDICAL | 2026-02-13 |
| K251915 | Amethyst HP PTA OTW 0.035 Catheter | Natec Medical , Ltd. | 2025-12-18 |
| 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 Angioplas... | Biotronik, Inc. | 2025-04-04 |
| 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. | 2025-02-27 |
| K241040 | Amethyst HP PTA OTW 0.035 Catheter | Natec Medical , Ltd. | 2024-12-18 |
| K242419 | 018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter | Creagh Medical Ltd. Dba Surmodics, Inc. | 2024-11-15 |
| K241740 | Finesse Injectable™ PTA Balloon Dilatation Catheter | Summa Therapeutics | 2024-07-16 |
| K241711 | Oscar Peripheral Multifunctional Catheter system | Biotronik, Inc. | 2024-07-11 |
| 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... | Boston Scientific Corporation | 2024-07-10 |
| K241025 | JADE PLUS PTA Balloon Dilatation Catheter | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2024-06-11 |
| K231402 | HP PTA Balloon Dilatation Catheter | Kossel Medtech (Suzhou) Co., Ltd. | 2023-12-20 |
| K230263 | Finesse™ Injectable PTA Balloon Dilatation Catheter | Summa Therapeutics, LLC | 2023-05-26 |
| K214009 | D·Kaptain PTA High Pressure Balloon Dilatation Catheter | Dk Medical Technology Co., Ltd. | 2023-04-05 |
| K230191 | Arise™ UHP Dilatation Catheter | Creagh Medical, Ltd. | 2023-03-22 |
| K222065 | Passeo-35 Xeo Peripheral Dilatation Catheter | Biotronik, Inc. | 2023-02-16 |
| K223177 | Highlander™ 014 PTA Balloon Dilatation Catheter | C.R. Bard, Inc. | 2023-01-20 |
| K221245 | PTA Balloon Dilatation Catheter | Kossel Medtech (Suzhou) Co., Ltd. | 2022-12-14 |
| K221414 | ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter | Silk Road Medical, Inc. | 2022-09-02 |
| K221832 | SABER .014 PTA Dilatation Catheter; SABERX .014 PTA Dilatation Catheter | Cordis US Corp | 2022-08-22 |
| K212215 | Tiche PTA Balloon Dilatation Catheter | Brosmed Medical Co., Ltd. | 2022-07-19 |
| K214038 | Oscar Peripheral Multifunctional Catheter system | Biotronik, Inc. | 2022-07-06 |
| K220410 | Ebony HP PTA OTW 0.035 Catheter | Natec Medical , Ltd. | 2022-06-29 |
| K221339 | Paladin Carotid Post-Dilation Balloon System with Integrated Embolic Protection | Contego Medical, Inc. | 2022-06-09 |
| K221057 | Viatrac 14 Plus Peripheral Dilatation Catheter | Abbott Vascular | 2022-05-05 |
| K213631 | Chocolate PTA Balloon Catheter | Medtronic, Inc. | 2021-12-15 |
| K201246 | PTA Balloon Catheter (PVQ), MIT PTA Balloon Catheter (PVQ) | Qualimed USA, LLC | 2021-08-03 |
| K211044 | Sublime Radial Access 018 RX Dilatation Catheter | Creagh Medical Ltd. (A Wholly Owned Subsidiary of Surmodics, | 2021-06-16 |
| K210626 | SABER .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter | Cordis Corporation | 2021-04-23 |
| K202231 | JADE | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2020-12-10 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08033477029603 | PACIFIC XTREME | MEDTRONIC, INC. | 2016-04-30 |
| 08033477029627 | PACIFIC XTREME | MEDTRONIC, INC. | 2016-04-30 |
| 08033477029641 | PACIFIC XTREME | MEDTRONIC, INC. | 2016-04-30 |
| 08033477029665 | PACIFIC XTREME | MEDTRONIC, INC. | 2016-04-30 |
| 08033477029702 | PACIFIC XTREME | MEDTRONIC, INC. | 2016-04-30 |
| 08033477029788 | PACIFIC XTREME | MEDTRONIC, INC. | 2016-04-30 |
| 08033477029818 | PACIFIC XTREME | MEDTRONIC, INC. | 2016-04-30 |
| 08033477029849 | PACIFIC XTREME | MEDTRONIC, INC. | 2016-04-30 |
| 08033477029573 | PACIFIC XTREME | MEDTRONIC, INC. | 2016-04-30 |
| 08033477029658 | PACIFIC XTREME | MEDTRONIC, INC. | 2016-04-28 |
| 08033477034584 | Amphirion Plus | MEDTRONIC, INC. | 2016-04-15 |
| 08033477034577 | Amphirion Plus | MEDTRONIC, INC. | 2016-04-15 |
| 08033477034560 | Amphirion Plus | MEDTRONIC, INC. | 2016-04-15 |
| 08033477034546 | Amphirion Plus | MEDTRONIC, INC. | 2016-04-15 |
| 08033477034485 | Amphirion Plus | MEDTRONIC, INC. | 2016-04-15 |
| 08033477034454 | Amphirion Plus | MEDTRONIC, INC. | 2016-04-15 |
| 08033477034430 | Amphirion Plus | MEDTRONIC, INC. | 2016-04-15 |
| 08033477034409 | Amphirion Plus | MEDTRONIC, INC. | 2016-04-15 |
| 08033477034393 | Amphirion Plus | MEDTRONIC, INC. | 2016-04-15 |
| 08033477034447 | Amphirion Plus | MEDTRONIC, INC. | 2016-04-14 |
| 08033477034461 | Amphirion Plus | MEDTRONIC, INC. | 2016-04-14 |
| 08033477034478 | Amphirion Plus | MEDTRONIC, INC. | 2016-04-14 |
| 08033477034492 | Amphirion Plus | MEDTRONIC, INC. | 2016-04-14 |
| 08033477034508 | Amphirion Plus | MEDTRONIC, INC. | 2016-04-14 |
| 08033477034515 | Amphirion Plus | MEDTRONIC, INC. | 2016-04-14 |
| 08033477034522 | Amphirion Plus | MEDTRONIC, INC. | 2016-04-14 |
| 08033477034539 | Amphirion Plus | MEDTRONIC, INC. | 2016-04-14 |
| 08033477034423 | Amphirion Plus | MEDTRONIC, INC. | 2016-04-14 |
| 08033477034553 | Amphirion Plus | MEDTRONIC, INC. | 2016-04-14 |
| 08033477034416 | Amphirion Plus | MEDTRONIC, INC. | 2016-04-14 |