Medical Device Manufacturer · US , Alameda , CA

Penumbra, Inc.

85 submissions · 83 cleared · Since 2005
85
Total
83
Cleared
0
Denied

Penumbra, Inc. — FDA 510(k) Submissions

Penumbra, Inc. has submitted 85 FDA 510(k) premarket notifications since 2005, of which 83 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Peripheral Mechanical Thrombectomy With Aspiration, Catheter, Thrombus Retriever, Device, Neurovascular Embolization, Catheter, Percutaneous, Catheter, Percutaneous, Neurovasculature . Use the specialty filter in the sidebar to narrow results.

85 devices
1–25 of 85
INDIGO? Aspiration System - Lightning Flash Aspiration Tubing with LINK
K251949 · QEW Peripheral Mechanical... · Cardiovascular
Feb 2026 225d
INDIGO? Aspiration System ? Lightning Flash Aspiration Tubing; INDIGO? Aspiration System ? Lightning Bolt Aspiration Tubing
K252612 · QEW Peripheral Mechanical... · Cardiovascular
Oct 2025 58d
Ruby XL System
K250079 · KRD Device, Vascular, For... · Cardiovascular
Mar 2025 60d
Penumbra System (Reperfusion Catheter RED 72)
K242104 · NRY Catheter, Thrombus Retriever · Neurology
Feb 2025 210d
Access25? Delivery Microcatheter
K242033 · QJP Catheter, Percutaneous,... · Neurology
Dec 2024 153d
Element Vascular Access System
K242520 · DYB Introducer, Catheter · Cardiovascular
Nov 2024 89d
Indigo? Aspiration System ? Lightning Bolt Aspiration Tubing
K242075 · QEW Peripheral Mechanical... · Cardiovascular
Sep 2024 71d
Indigo? Aspiration System ? Aspiration Catheter 6X
K242319 · QEW Peripheral Mechanical... · Cardiovascular
Sep 2024 29d
Indigo? Lightning Flash Aspiration System ? Select +? Catheter
K241399 · QEW Peripheral Mechanical... · Cardiovascular
Jun 2024 25d
MIDWAY Delivery Catheter (MIDWAY 43 Delivery Catheter; MIDWAY 62 Delivery Catheter)
K233201 · QJP Catheter, Percutaneous,... · Neurology
Mar 2024 181d
Indigo? Aspiration System - Lightning? Flash
K240030 · QEW Peripheral Mechanical... · Cardiovascular
Feb 2024 29d
Penumbra LP Coil System
K230284 · HCG Device, Neurovascular... · Neurology
Oct 2023 265d
Indigo? Aspiration System ? Lightning Bolt Aspiration Tubing
K223186 · QEW Peripheral Mechanical... · Cardiovascular
Feb 2023 124d
Indigo Aspiration System - Lightning Flash
K222358 · QEW Peripheral Mechanical... · Cardiovascular
Dec 2022 138d
Penumbra System (Reperfusion Catheter RED 43)
K222808 · NRY Catheter, Thrombus Retriever · Neurology
Dec 2022 95d
BENCHMARK BMX81 Access System
K221822 · QJP Catheter, Percutaneous,... · Neurology
Nov 2022 134d
INDIGO Aspiration System (CAT RX Aspiration Catheter and Separator 4)
K220683 · QEW Peripheral Mechanical... · Cardiovascular
Oct 2022 210d
Benchmark BMX96 Access System
K213390 · QJP Catheter, Percutaneous,... · Neurology
Aug 2022 307d
Benchmark Intracranial Access System
K212838 · QJP Catheter, Percutaneous,... · Neurology
May 2022 262d
Penumbra System (Reperfusion Catheter RED 72)
K211654 · NRY Catheter, Thrombus Retriever · Neurology
Aug 2021 80d
Penumbra System (RED 68 Reperfusion Catheter)
K211411 · NRY Catheter, Thrombus Retriever · Neurology
Jul 2021 56d
Penumbra System (Reperfusion Catheter RED 62)
K203440 · NRY Catheter, Thrombus Retriever · Neurology
May 2021 178d
Indigo Aspiration System - Lightning Aspiration Tubing
K210323 · QEW Peripheral Mechanical... · Cardiovascular
Feb 2021 22d
Indigo System Aspiration Catheter 7, Indigo Aspiration System Separator 7, Lightning 7
K210083 · QEW Peripheral Mechanical... · Cardiovascular
Feb 2021 28d
Indigo Aspiration System - Aspiration Catheter 12 and Separator 12
K202821 · QEW Peripheral Mechanical... · Cardiovascular
Nov 2020 55d

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