← Every applicant
Penumbra, Inc. FDA Approvals
0 new drug approvals and 26 device clearances on file. Matched by name to PEN.
Newest first
A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.
| Product |
|---|
| Penumbra System (Thunderbolt Aspiration Tubing)510(k)Jun 10, 2026Cardiovascular |
| INDIGO® Aspiration System INDIGO Link510(k)Apr 24, 2026Cardiovascular |
| INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK510(k)Feb 5, 2026Cardiovascular |
| INDIGO® Aspiration System Lightning Flash Aspiration Tubing; INDIGO® Aspiration System Lightning Bolt Aspiration Tubing510(k)Oct 16, 2025Cardiovascular |
| Ruby XL System510(k)Mar 14, 2025Cardiovascular |
| Penumbra System (Reperfusion Catheter RED 72)510(k)Feb 13, 2025Cardiovascular |
| Access25 Delivery Microcatheter510(k)Dec 11, 2024Cardiovascular |
| Element Vascular Access System510(k)Nov 20, 2024Cardiovascular |
| Indigo® Aspiration System Lightning Bolt Aspiration Tubing510(k)Sep 25, 2024Cardiovascular |
| Indigo® Aspiration System Aspiration Catheter 6X510(k)Sep 3, 2024Cardiovascular |
| Indigo® Lightning Flash Aspiration System Select + Catheter510(k)Jun 10, 2024Cardiovascular |
| MIDWAY Delivery Catheter (MIDWAY 43 Delivery Catheter; MIDWAY 62 Delivery Catheter)510(k)Mar 27, 2024Cardiovascular |
| Indigo® Aspiration System - Lightning® Flash510(k)Feb 2, 2024Cardiovascular |
| Penumbra LP Coil System510(k)Oct 25, 2023Neurology |
| Indigo® Aspiration System Lightning Bolt Aspiration Tubing510(k)Feb 13, 2023Cardiovascular |
| Penumbra System (Reperfusion Catheter RED 43)510(k)Dec 20, 2022Cardiovascular |
| Indigo Aspiration System - Lightning Flash510(k)Dec 20, 2022Cardiovascular |
| BENCHMARK BMX81 Access System510(k)Nov 4, 2022Cardiovascular |
| INDIGO Aspiration System (CAT RX Aspiration Catheter and Separator 4)510(k)Oct 4, 2022Cardiovascular |
| Benchmark BMX96 Access System510(k)Aug 18, 2022Cardiovascular |
| Benchmark Intracranial Access System510(k)May 27, 2022Cardiovascular |
| Penumbra System (Reperfusion Catheter RED 72)510(k)Aug 16, 2021Cardiovascular |
| Penumbra System (RED 68 Reperfusion Catheter)510(k)Jul 1, 2021Cardiovascular |
| Penumbra System (Reperfusion Catheter RED 62)510(k)May 20, 2021Cardiovascular |
| Indigo Aspiration System - Lightning Aspiration Tubing510(k)Feb 26, 2021Cardiovascular |
| Indigo System Aspiration Catheter 7, Indigo Aspiration System Separator 7, Lightning 7510(k)Feb 9, 2021Cardiovascular |