Search FDA 510(k) Devices

4,872 clearances indexed · Search by device name, K-number, manufacturer or product code

85 results for "Penumbra, Inc."
1–24 of 85
Cleared Feb 05, 2026
INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK
K251949 · QEW
Penumbra, Inc.
Cardiovascular · 225d
Cleared Oct 16, 2025
INDIGO® Aspiration System – Lightning Flash Aspiration Tubing
K252612 · QEW
Penumbra, Inc.
Cardiovascular · 58d
Cleared Mar 14, 2025
Ruby XL System
K250079 · KRD
Penumbra, Inc.
Cardiovascular · 60d
Cleared Feb 13, 2025
Penumbra System (Reperfusion Catheter RED 72)
K242104 · NRY
Penumbra, Inc.
Neurology · 210d
Cleared Dec 11, 2024
Access25™ Delivery Microcatheter
K242033 · QJP
Penumbra, Inc.
Neurology · 153d
Cleared Nov 20, 2024
Element Vascular Access System
K242520 · DYB
Penumbra, Inc.
Cardiovascular · 89d
Cleared Sep 25, 2024
Indigo® Aspiration System – Lightning Bolt Aspiration Tubing
K242075 · QEW
Penumbra, Inc.
Cardiovascular · 71d
Cleared Sep 03, 2024
Indigo® Aspiration System – Aspiration Catheter 6X
K242319 · QEW
Penumbra, Inc.
Cardiovascular · 29d
Cleared Jun 10, 2024
Indigo® Lightning Flash Aspiration System – Select +™ Catheter
K241399 · QEW
Penumbra, Inc.
Cardiovascular · 25d
Cleared Mar 27, 2024
MIDWAY Delivery Catheter (MIDWAY 43 Delivery Catheter
K233201 · QJP
Penumbra, Inc.
Neurology · 181d
Cleared Feb 02, 2024
Indigo® Aspiration System - Lightning® Flash
K240030 · QEW
Penumbra, Inc.
Cardiovascular · 29d
Cleared Oct 25, 2023
Penumbra LP Coil System
K230284 · HCG
Penumbra, Inc.
Neurology · 265d
Cleared Feb 13, 2023
Indigo® Aspiration System – Lightning Bolt Aspiration Tubing
K223186 · QEW
Penumbra, Inc.
Cardiovascular · 124d
Cleared Dec 20, 2022
Penumbra System (Reperfusion Catheter RED 43)
K222808 · NRY
Penumbra, Inc.
Neurology · 95d
Cleared Dec 20, 2022
Indigo Aspiration System - Lightning Flash
K222358 · QEW
Penumbra, Inc.
Cardiovascular · 138d
Cleared Nov 04, 2022
BENCHMARK BMX81 Access System
K221822 · QJP
Penumbra, Inc.
Neurology · 134d
Cleared Oct 04, 2022
INDIGO Aspiration System (CAT RX Aspiration Catheter and Separator 4)
K220683 · QEW
Penumbra, Inc.
Cardiovascular · 210d
Cleared Aug 18, 2022
Benchmark BMX96 Access System
K213390 · QJP
Penumbra, Inc.
Neurology · 307d
Cleared May 27, 2022
Benchmark Intracranial Access System
K212838 · QJP
Penumbra, Inc.
Neurology · 262d
Cleared Aug 16, 2021
Penumbra System (Reperfusion Catheter RED 72)
K211654 · NRY
Penumbra, Inc.
Neurology · 80d
Cleared Jul 01, 2021
Penumbra System (RED 68 Reperfusion Catheter)
K211411 · NRY
Penumbra, Inc.
Neurology · 56d
Cleared May 20, 2021
Penumbra System (Reperfusion Catheter RED 62)
K203440 · NRY
Penumbra, Inc.
Neurology · 178d
Cleared Feb 26, 2021
Indigo Aspiration System - Lightning Aspiration Tubing
K210323 · QEW
Penumbra, Inc.
Cardiovascular · 22d
Cleared Feb 09, 2021
Indigo System Aspiration Catheter 7, Indigo Aspiration System Separator 7,...
K210083 · QEW
Penumbra, Inc.
Cardiovascular · 28d