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. Cardiovascular ✕
39 devices
Cleared
Apr 24, 2026
INDIGO® Aspiration System – INDIGO Link
Cardiovascular
59d
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
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
Feb 02, 2024
Indigo® Aspiration System - Lightning® Flash
Cardiovascular
29d
Cleared
Feb 13, 2023
Indigo® Aspiration System – Lightning Bolt Aspiration Tubing
Cardiovascular
124d
Cleared
Dec 20, 2022
Indigo Aspiration System - Lightning Flash
Cardiovascular
138d
Cleared
Oct 04, 2022
INDIGO Aspiration System (CAT RX Aspiration Catheter and Separator 4)
Cardiovascular
210d
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