Boston Scientific
FDA 510(k) & PMA Approved Devices — 50 products
Total Devices50
Categories0
Latest FDA decision
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K262460 | Rezum System | KNS | 2026-09-03 | View |
| 510(k) | K253692 | AVVIGO™+ Multi-Modality Guidance System | DQK | 2026-08-21 | View |
| 510(k) | K262406 | EluPro Antibiotic-Eluting BioEnvelope | FTM | 2026-08-12 | View |
| 510(k) | K260816 | OptiCross Coronary Imaging Catheter (H749518110); OptiCross 6 Coronary Imaging Catheter (H7495181160); OptiCross HD Coronary Imaging Catheter (H74939352040); OptiCross 6 HD Coronary Imaging Catheter (H74939354080); OptiCross Coronary Imaging Catheter (Bagless) (H749518130); OptiCross 6 Coronary Imaging Catheter (Bagless) (H7495181360); OptiCross HD Coronary Imaging Catheter (Bagless) (H74939352050); OptiCross 6 HD Coronary Imaging Catheter (Bagless) (H74939354090) | OBJ | 2026-04-08 | View |
| 510(k) | K252910 | Orca Air/Water and Suction Valves | ODC | 2025-10-09 | View |
| 510(k) | K251291 | Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System and Pushers | FGE | 2025-07-03 | View |
| 510(k) | K250468 | iSLEEVE Introducer Set | DYB | 2025-03-20 | View |
| 510(k) | K242950 | WallFlex Biliary PLUS RX Stent System | FGE | 2024-12-06 | View |
| 510(k) | K242507 | OBSIDIO™ Conformable Embolic | KRD | 2024-10-03 | View |
| 510(k) | K240464 | WallFlex Biliary RX Stent System; Epic Biliary Stent System; WallFlex Biliary RX Fully Covered Stent System RMV | FGE | 2024-08-30 | View |
| 510(k) | K233939 | Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System | ESW | 2024-04-29 | View |
| 510(k) | K234002 | ICEfx Cryoablation System (FPRCH8000-02) | GEH | 2024-03-13 | View |
| 510(k) | K232633 | Gold Probe Bipolar Electrohemostasis Catheter; Injection Gold Probe Bipolar Electrohemostasis Catheter | KNS | 2023-11-28 | View |
| 510(k) | K232635 | IceSeed 1.5 CX 90º Needle (H7493967433170); IceSeed 1.5 CX S 90º Needle (H7493967233100) | GEH | 2023-11-22 | View |
| 510(k) | K231176 | Stingray LP Catheter | DQY | 2023-05-25 | View |
| 510(k) | K230503 | Polaris X™ Catheter Cable, Blazer™ Dx-20 Catheter Cable | DRF | 2023-04-25 | View |
| 510(k) | K220866 | EKOS+ Endovascular Device | QEY | 2022-04-20 | View |
| 510(k) | K220629 | Emerge Monorail PTCA Dilatation Catheter | LOX | 2022-03-24 | View |
| 510(k) | K211080 | EkoSonic Endovascular Device | QEY | 2021-11-19 | View |
| 510(k) | K210925 | Flexiva Pulse Laser Fiber, Flexiva Pulse Tractip Laser Fiber, Flexiva Pulse ID Laser Fiber, Flexiva Pulse ID TracTip Laser Fiber | GEX | 2021-04-28 | View |
No matching devices.