Penumbra, Inc.
FDA 510(k) & PMA Approved Dispositivos — 60 products
Publicidade
Total de dispositivos60
Categorias0
Última decisão da FDA
| Tipo | Número | Nome do dispositivo | Código | Data | Ações |
|---|---|---|---|---|---|
| 510(k) | K250690 | Penumbra System (Thunderbolt Aspiration Tubing) | NRY | 2026-06-10 | Ver |
| 510(k) | K260599 | INDIGO® Aspiration System – INDIGO Link | QEW | 2026-04-24 | Ver |
| 510(k) | K251949 | INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK | QEW | 2026-02-05 | Ver |
| 510(k) | K252612 | INDIGO® Aspiration System – Lightning Flash Aspiration Tubing; INDIGO® Aspiration System – Lightning Bolt Aspiration Tubing | QEW | 2025-10-16 | Ver |
| 510(k) | K250079 | Ruby XL System | KRD | 2025-03-14 | Ver |
| 510(k) | K242104 | Penumbra System (Reperfusion Catheter RED 72) | NRY | 2025-02-13 | Ver |
| 510(k) | K242033 | Microcateter de Entrega Access25™ | QJP | 2024-12-11 | Ver |
| 510(k) | K242520 | Element Vascular Access System | DYB | 2024-11-20 | Ver |
| 510(k) | K242075 | Indigo® Aspiration System – Lightning Bolt Aspiration Tubing | QEW | 2024-09-25 | Ver |
| 510(k) | K242319 | Indigo® Aspiration System – Aspiration Catheter 6X | QEW | 2024-09-03 | Ver |
| 510(k) | K241399 | Indigo® Lightning Flash Aspiration System – Select +™ Catheter | QEW | 2024-06-10 | Ver |
| 510(k) | K233201 | MIDWAY Delivery Catheter (MIDWAY 43 Delivery Catheter; MIDWAY 62 Delivery Catheter) | QJP | 2024-03-27 | Ver |
| 510(k) | K240030 | Indigo® Aspiration System - Lightning® Flash | QEW | 2024-02-02 | Ver |
| 510(k) | K230284 | Penumbra LP Coil System | HCG | 2023-10-25 | Ver |
| 510(k) | K223186 | Indigo® Aspiration System – Lightning Bolt Aspiration Tubing | QEW | 2023-02-13 | Ver |
| 510(k) | K222808 | Penumbra System (Reperfusion Catheter RED 43) | NRY | 2022-12-20 | Ver |
| 510(k) | K222358 | Indigo Aspiration System - Lightning Flash | QEW | 2022-12-20 | Ver |
| 510(k) | K221822 | BENCHMARK BMX81 Access System | QJP | 2022-11-04 | Ver |
| 510(k) | K220683 | INDIGO Aspiration System (CAT RX Aspiration Catheter and Separator 4) | QEW | 2022-10-04 | Ver |
| 510(k) | K213390 | Benchmark BMX96 Access System | QJP | 2022-08-18 | Ver |
Nenhum dispositivo correspondente.