510(k) K000570
- Device
- BLUE MAX BALLOON DILATATION CATHETER, MAXFORCE BALLOON CATHETER, XXL BALLOON DILATATION CATHATER, SYMMETRY BALLOON DILA
- Applicant
- BOSTON SCIENTIFIC CORP.
- 510(k) number
- K000570
- Product code
- LIT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2000-04-13
- Date received
- 2000-02-22
- Regulation
- 870.1250
- Classification name
- Catheter, Angioplasty, Peripheral, Transluminal
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- TERRY A MCGOVERN
- Address
- One Boston Scientific Pl. Natick, MA US 01760 01760
FDA Registration Numbers#
- 3011471056
- 3011142981
- 3027395815
- 2183870
- 1018233
- 2134265
- 3019677404
- 3004091615
- 3013391155
- 3005580113
- 2011171
- 3009018440
- 2134626
- 3010432890
- 3009965866
- 3010391265
- 1000121056
- 2939561
- 3015453963
- 3004415014
- 1318694
- 2024168
- 3022627847
- 3010220595
- 1054241
- 2124215
- 2183744
- 3005718570
- 3015002281
- 3008261722
- 1028232
- 3014222368
- 3006550224
- 3005994106
- 2024024
- 3015910259
- 3002807315
- 2030598
- 3002807090
- 1319639
- 1647149
- 1313046
- 3016678045
- 1043214
- 3004730544
- 9614654
- 3010273872
- 1820334
- 1219930
- 3016927279
- 3013944123
- 3007738736
- 3002806603
- 1055236
- 3002807314
- 3003775186
- 3008700817
- 1225687
- 3016761372
- 1282497
- 3006082230
- 1220452
- 1646831
- 3012448339
- 3010291427
- 3012050423
- 1721686
- 1721676
- 3015190176
- 1016427
- 3016591327
- 3008361782
- 9681260
- 9617601
- 3011088743
- 1000563940
- 2020394
- 3009564766
- 3000247873
- 2528981
Source Documents#
Other 510(k) Records For Product Code LIT #
| 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 Angioplasty Catheter; Pantera LEO Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter | 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 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 | 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 |
Legacy Summary#
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FDA Review#
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