Penumbra, Inc.
FDA 510(k) & PMA Approved Devices — 60 products
Total Devices60
Categories10
Latest FDA decision2026-06-10
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K250690 | Penumbra System (Thunderbolt Aspiration Tubing) | NRY | 2026-06-10 | View |
| 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 |
No matching devices.
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Related Clinical Trials
NCT04798261Study of the Long-Term Safety and Outcomes of Treating Pulmonary Embolism With the Indigo Aspiration SystemRECRUITINGNCT05003843BOLT: Study of the Indigo® Aspiration System When Used in Patients With Deep Vein ThrombosisACTIVE_NOT_RECRUITINGNCT05437055THUNDER: Acute Ischemic Stroke Study With the Penumbra System® Including Thunderbolt™ Aspiration TubingCOMPLETEDNCT05684796Comparison of Two Pulmonary Embolism TreatmentsCOMPLETEDNCT06747117A Study of Patients With Lower Extremity Acute Limb Ischemia to Remove Thrombus With the Indigo™ Aspiration System (STRIDE II)RECRUITINGNCT07107022Study to Collect Real-world Performance and Safety Data on Penumbra System® in Population With Acute Ischemic Stroke (AIS).RECRUITINGNCT07749170FORWARD: Functional Outcomes in Real-World Treatment And Revascularization of Non-dominant and Distal M2 OcclusionsRECRUITINGNCT03265860Intravoxel Incoherent Motion Prognostic Value in the Initial Evaluation of Patients With Acute Ischemic Strokes Using 3 Tesla Magnetic Resonance ImagingCOMPLETEDNCT03923439High B Value Diffusion and StrokeCOMPLETEDNCT05871502Glycemia and Ischemia Reperfusion Brain Injury in Patients With Acute Cerebral Infarction Treated With Mechanical ThrombectomyCOMPLETED