Penumbra, Inc.
FDA 510(k) & PMA Approved Devices — 59 products
Total Devices59
Categories10
Latest Approval2026-04-24
| Type | Number | Device Name | Code | Date | |
|---|---|---|---|---|---|
| 510(k) | K260599 | INDIGO® Aspiration System INDIGO Link | QEW | 2026-04-24 | View |
| 510(k) | K251949 | INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK | QEW | 2026-02-05 | View |
| 510(k) | K252612 | INDIGO® Aspiration System Lightning Flash Aspiration Tubing; INDIGO® Aspiration System Lightning Bolt Aspiration Tubing | QEW | 2025-10-16 | View |
| 510(k) | K250079 | Ruby XL System | KRD | 2025-03-14 | View |
| 510(k) | K242104 | Penumbra System (Reperfusion Catheter RED 72) | NRY | 2025-02-13 | View |
| 510(k) | K242033 | Access25 Delivery Microcatheter | QJP | 2024-12-11 | View |
| 510(k) | K242520 | Element Vascular Access System | DYB | 2024-11-20 | View |
| 510(k) | K242075 | Indigo® Aspiration System Lightning Bolt Aspiration Tubing | QEW | 2024-09-25 | View |
| 510(k) | K242319 | Indigo® Aspiration System Aspiration Catheter 6X | QEW | 2024-09-03 | View |
| 510(k) | K241399 | Indigo® Lightning Flash Aspiration System Select + Catheter | QEW | 2024-06-10 | View |
| 510(k) | K233201 | MIDWAY Delivery Catheter (MIDWAY 43 Delivery Catheter; MIDWAY 62 Delivery Catheter) | QJP | 2024-03-27 | View |
| 510(k) | K240030 | Indigo® Aspiration System - Lightning® Flash | QEW | 2024-02-02 | View |
| 510(k) | K230284 | Penumbra LP Coil System | HCG | 2023-10-25 | View |
| 510(k) | K223186 | Indigo® Aspiration System Lightning Bolt Aspiration Tubing | QEW | 2023-02-13 | View |
| 510(k) | K222358 | Indigo Aspiration System - Lightning Flash | QEW | 2022-12-20 | View |
| 510(k) | K222808 | Penumbra System (Reperfusion Catheter RED 43) | NRY | 2022-12-20 | View |
| 510(k) | K221822 | BENCHMARK BMX81 Access System | QJP | 2022-11-04 | View |
| 510(k) | K220683 | INDIGO Aspiration System (CAT RX Aspiration Catheter and Separator 4) | QEW | 2022-10-04 | View |
| 510(k) | K213390 | Benchmark BMX96 Access System | QJP | 2022-08-18 | View |
| 510(k) | K212838 | Benchmark Intracranial Access System | QJP | 2022-05-27 | View |
No matching devices.
Page 1 of 3