Penumbra, Inc. - FDA 510(k) Cleared Devices
85
Total
83
Cleared
0
Denied
Penumbra, Inc. has 83 FDA 510(k) cleared medical devices. Based in Alameda, US.
Latest FDA clearance: Feb 2026. Active since 2005. Primary specialty: Neurology.
Browse the FDA 510(k) cleared devices submitted by Penumbra, Inc. Filter by specialty or product code using the sidebar.
FDA 510(k) cleared devices by Penumbra, Inc.
85 devices
Cleared
Feb 05, 2026
INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK
Cardiovascular
225d
Cleared
Oct 16, 2025
INDIGO® Aspiration System – Lightning Flash Aspiration Tubing
Cardiovascular
58d
Cleared
Mar 14, 2025
Ruby XL System
Cardiovascular
60d
Cleared
Feb 13, 2025
Penumbra System (Reperfusion Catheter RED 72)
Neurology
210d
Cleared
Dec 11, 2024
Access25™ Delivery Microcatheter
Neurology
153d
Cleared
Nov 20, 2024
Element Vascular Access System
Cardiovascular
89d
Cleared
Sep 25, 2024
Indigo® Aspiration System – Lightning Bolt Aspiration Tubing
Cardiovascular
71d
Cleared
Sep 03, 2024
Indigo® Aspiration System – Aspiration Catheter 6X
Cardiovascular
29d
Cleared
Jun 10, 2024
Indigo® Lightning Flash Aspiration System – Select +™ Catheter
Cardiovascular
25d
Cleared
Mar 27, 2024
MIDWAY Delivery Catheter (MIDWAY 43 Delivery Catheter
Neurology
181d
Cleared
Feb 02, 2024
Indigo® Aspiration System - Lightning® Flash
Cardiovascular
29d
Cleared
Oct 25, 2023
Penumbra LP Coil System
Neurology
265d
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