PENUMBRA, INC.

FDA Device Registration & Listing · Alameda, CA, US · Registration 3005168196

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3005168196
FEI Number
3005168196
Entity Name
PENUMBRA, INC.
City/State/Country
Alameda, CA, US
Establishment Address
One Penumbra Place, Alameda, CA 94502, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
PENUMBRA, INC. (Owner Number: 9072336)
Owner / Operator Contact Address
One Penumbra Place, Alameda, CA 94502, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K200771
PMA Number
N/A

All Registered Proprietary Names

Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology ASPIRATION PUMP Indigo® Aspiration System Penumbra System (RED 68 Reperfusion Catheter) Penumbra System® (Reperfusion Catheter RED™ 43) Indigo System INDIGO Aspiration System (CAT RX Aspiration Catheter and Separator 4) Indigo® Aspiration System – Lightning® Flash Penumbra Separator 054 Penumbra Reperfusion Catheter 054 Benchmark Intracranial Access System Benchmark System Penumbra LP Coil System Penumbra Coil System PC 400 Ruby Coil System Penumbra Engine Pump Access25™ Delivery Microcatheter Benchmark BMX96 System BMX 81 Delivery Catheter Penumbra System (Reperfusion Catheter RED 72) Penumbra Separator Penumbra Reperfusion Catheter Penumbra Aspiration Tubing Penumbra System (Thunderbolt Aspiration Tubing) Penumbra Indigo System JET™7Reperfusion Catheter with MAX Delivery Device (JET™7MAX) Artemis Neuro Evacuation Device Lantern Microcatheter Penumbra System (Reperfusion Catheter RED 72) Indigo® Aspiration System - Aspiration Catheter 12 and Separator 12 Penumbra System ACE 68 Reperfusion Catheter INDIGO® Aspiration System - INDIGO Link POD System Indigo Aspiration System – Lightning Aspiration Tubing Penumbra ACE System Indigo Aspiration System (CAT RX and Separator 4) - Penumbra Engine Pump and Canister Apollo System POD Packing Coil Penumbra System Ruby XL System Indigo® Aspiration System – Lightning Bolt Aspiration Tubing Benchmark BMX96 Access System Penumbra Smart Coil System Penumbra System ACE 68 Reperfusion Catheter Penumbra System Element Vascular Access System Penumbra 3D Revascularization Device Penumbra Aspiration System Indigo® Aspiration System - Aspiration Catheter 12 and Separator 12 Indigo System Indigo® Aspiration System – Lightning® Flash Aspiration Tubing Indigo® Aspiration System – Lightning® Bolt Aspiration Tubing MIDWAY Delivery Catheter (MIDWAY 43 Delivery Catheter; MIDWAY 62 Delivery Catheter) Penumbra Indigo System Neuron Intracranial Access System Indigo Lightning Flash Aspiration System - Select + Catheter Neuron MAX Penumbra LP Coil System INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK Indigo Aspiration System - Aspiration Catheter 7 and Separator 7 Indigo Aspiration System – Lightning Aspiration Tubing

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2020-09-02
JCX Apparatus, Suction, Ward Use, Portable, Ac-Powered General, Plastic Surgery Class 2 878.4780 2006-05-08
BTA Pump, Portable, Aspiration (Manual Or Powered) General, Plastic Surgery Class 2 878.4780 2006-05-08
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2020-01-07
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2021-07-12
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2023-01-03
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2012-10-16
QEX Coronary Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2022-10-14
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2022-10-14
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2023-01-03
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2009-10-06
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2019-06-27
QJP Catheter, Percutaneous, Neurovasculature Cardiovascular Class 2 870.1250 2022-08-24
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2022-08-24
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2015-01-27
HCG Device, Neurovascular Embolization Neurology Class 2 882.5950 2023-10-29
KRD Device, Vascular, For Promoting Embolization Cardiovascular Class 2 870.3300 2023-10-29
HCG Device, Neurovascular Embolization Neurology Class 2 882.5950 2011-11-15
KRD Device, Vascular, For Promoting Embolization Cardiovascular Class 2 870.3300 2011-11-15
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2024-09-24
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2018-10-06
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2024-12-12
QJP Catheter, Percutaneous, Neurovasculature Cardiovascular Class 2 870.1250 2024-12-12
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2020-06-11
QJP Catheter, Percutaneous, Neurovasculature Cardiovascular Class 2 870.1250 2022-11-08
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2022-11-08
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2021-08-19
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2008-01-15
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2026-06-11
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2024-09-26
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2018-05-09
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2020-03-24
GWG Endoscope, Neurological Neurology Class 2 882.1480 2017-10-04
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2015-12-04
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2025-02-18
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2020-11-20
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2017-02-10
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2026-04-28
KRD Device, Vascular, For Promoting Embolization Cardiovascular Class 2 870.3300 2015-01-27
HCG Device, Neurovascular Embolization Neurology Class 2 882.5950 2015-01-27
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2020-03-24
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2015-07-02
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2019-03-18
QEX Coronary Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2019-03-18
GWG Endoscope, Neurological Neurology Class 2 882.1480 2015-01-27
KRD Device, Vascular, For Promoting Embolization Cardiovascular Class 2 870.3300 2017-07-26
HCG Device, Neurovascular Embolization Neurology Class 2 882.5950 2017-07-26
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2010-10-29
KRD Device, Vascular, For Promoting Embolization Cardiovascular Class 2 870.3300 2025-03-21
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2023-02-17
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2022-08-24
QJP Catheter, Percutaneous, Neurovasculature Cardiovascular Class 2 870.1250 2022-08-24
HCG Device, Neurovascular Embolization Neurology Class 2 882.5950 2015-10-15
KRD Device, Vascular, For Promoting Embolization Cardiovascular Class 2 870.3300 2015-10-15
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2017-02-10
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2019-01-02
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2024-12-09
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2017-05-09
QEX Coronary Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2017-02-10
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2017-02-10
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2020-06-19
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2015-07-02
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2025-11-21
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2024-03-29
QJP Catheter, Percutaneous, Neurovasculature Cardiovascular Class 2 870.1250 2024-03-29
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2016-06-10
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2010-10-29
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2024-06-27
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2011-11-15
HCG Device, Neurovascular Embolization Neurology Class 2 882.5950 2020-01-07
KRD Device, Vascular, For Promoting Embolization Cardiovascular Class 2 870.3300 2020-01-07
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2026-03-06
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2020-09-02
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2020-09-02

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

PENUMBRA, INC.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3016591327 Penumbra Inc. Roseville, CA, US
3013758550 Penumbra Inc. Livermore, CA, US
3015615738 Penumbra Inc. Salt Lake City, UT, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K033736 Concentric Medical, Inc. MERCI RETRIEVER, MODELS 90065, 90066 2004-08-11
K082762 Aardvark Medical AARDVARK NASAL IRRIGATION AND ASPIRATION DEVICE 2008-11-12
K241362 Surmodics,Inc. Pounce XL Thrombectomy System (PTS-1011-7F135) 2024-09-11
K220887 Inari Medical Mini-ClotTriever Thrombectomy System 2022-08-04
K250421 Inari Medical, Inc. InThrill™ Thrombectomy System 2025-05-12

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0001-2010 Penumbra Inc. 2
Penumbra Neuron Delivery Catheter 070, percutaneous catheter, catalog numbers PND6F0701058, PND6F070956, PND6F0701058M, and PND6F070956M; manufactured by Penumbra, Inc., Alameda, CA. Indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
Z-0038-05 Kinetic Concepts, Inc 2
V.A.C. X-Large Granufoam Dressing Part Numbers M6275065/5, V.A.C. ATS and V.A.C. Freedom and M6275043/5 V.A.C. Classic. Manufactured by Kinetic Concepts, Inc., San Antonio, Texas 78230
Z-0035-2007 Haemonetics Corporation 2
SmartSuction Harmony Powered Suction Device Model Number: HAR-E-115-US
Z-0021-2025 Stryker Neurovascular 2
The Trevo Trak 21 Microcatheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker(s) on the distal end and a luer hub on the proximal end. The catheter shaft has a hydrophilic coating on the distal 100cm to reduce friction during use. The radiopaque shaft and distal marker(s) facilitate fluoroscopic visualization. A rotating hemostatic valve with side-arm adapter is provided with each microcatheter.
Z-0003-2014 Cordis Corporation 2
Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introduction of interventional and/or diagnostic devices into the coronary or peripheral vascular system.

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3015615738 Penumbra Inc. Salt Lake City, UT, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005168196. Last updated year: 2026. Please use registration number 3005168196 when referencing this establishment in official correspondence.
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