Penumbra, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Penumbra System (Thunderbolt Aspiration Tubing), INDIGO® Aspiration System – INDIGO Link, INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK
87
Total
85
Cleared
0
Denied
FDA 510(k) Regulatory Record - Penumbra, Inc. Neurology ✕
45 devices
Cleared
CT
Jun 10, 2026
Penumbra System (Thunderbolt Aspiration Tubing)
Neurology
460d
Cleared
Feb 13, 2025
Penumbra System (Reperfusion Catheter RED 72)
Neurology
210d
Cleared
Dec 11, 2024
Access25™ Delivery Microcatheter
Neurology
153d
Cleared
Mar 27, 2024
MIDWAY Delivery Catheter (MIDWAY 43 Delivery Catheter
Neurology
181d
Cleared
Oct 25, 2023
Penumbra LP Coil System
Neurology
265d
Cleared
Dec 20, 2022
Penumbra System (Reperfusion Catheter RED 43)
Neurology
95d
Cleared
Nov 04, 2022
BENCHMARK BMX81 Access System
Neurology
134d
Cleared
Aug 18, 2022
Benchmark BMX96 Access System
Neurology
307d
Cleared
May 27, 2022
Benchmark Intracranial Access System
Neurology
262d
Cleared
Aug 16, 2021
Penumbra System (Reperfusion Catheter RED 72)
Neurology
80d
Cleared
Jul 01, 2021
Penumbra System (RED 68 Reperfusion Catheter)
Neurology
56d
Cleared
May 20, 2021
Penumbra System (Reperfusion Catheter RED 62)
Neurology
178d
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