Penumbra Inc.

FDA Device Registration & Listing · Roseville, CA, US · Registration 3016591327

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
3016591327
FEI Number
3016591327
Entity Name
Penumbra Inc.
City/State/Country
Roseville, CA, US
Establishment Address
630 Roseville Parkway, Roseville, CA 95747, 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
K242319
PMA Number
N/A

All Registered Proprietary Names

Penumbra System® (Reperfusion Catheter RED™ 43) Indigo Aspiration System – Lightning Aspiration Tubing Penumbra System (Reperfusion Catheter RED 72) MIDWAY Delivery Catheter (MIDWAY 43 Delivery Catheter; MIDWAY 62 Delivery Catheter) Element Vascular Access System Neuron Intracranial Access System Penumbra System Penumbra System ACE JET™7Reperfusion Catheter with MAX Delivery Device (JET™7MAX) Benchmark System Penumbra Apollo System Penumbra ACE System BMX 81 Delivery Catheter POD Packing Coil Penumbra System MAX Indigo® Aspiration System – Lightning® Flash Aspiration Tubing Indigo® Aspiration System – Lightning® Bolt Aspiration Tubing Indigo System Smart Coil Penumbra LP Coil System Penumbra POD Embolization Coil Penumbra Ruby Embolization Coil Penumbra PC400 Embolization Coil Artemis Neuro Evacuation Device Penumbra System MAX Penumbra Aspiration System Indigo Aspiration System - Aspiration Catheter 7 and Separator 7 Indigo® Aspiration System – Lightning® Flash Penumbra System ACE 68 Reperfusion Catheter Neuron Intracranial Access System Neuron MAX Benchmark Intracranial Access System Penumbra Catheter Penumbra System JET Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology Penumbra Separator 054 Penumbra Reperfusion Catheter 054 Neuron Select Catheter Neuron Delivery Catheter Indigo Aspiration System - Lightning Flash Reperfusion Catheter RED™ 62 Penumbra System ACE 68 Reperfusion Catheter Access25™ Delivery Microcatheter Pump MAX CAT Rx Penumbra 3D Revascularization Device INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK Penumbra System Indigo® Aspiration System - Aspiration Catheter 12 and Separator 12 Indigo Lightning Flash Aspiration System - Select + Catheter Ruby XL System Penumbra Indigo System ASPIRATION PUMP Indigo Aspiration System – Lightning Aspiration Tubing Penumbra Coil System PC 400 Ruby Coil System Penumbra System (RED 68 Reperfusion Catheter) Penumbra Separator Penumbra Reperfusion Catheter Penumbra Aspiration Tubing Benchmark BMX96 Access System Penumbra Engine Pump Indigo System Indigo Aspiration System (CAT RX and Separator 4) - Penumbra Engine Pump and Canister Penumbra System Engine Pump Penumbra DDC Catheters Penumbra LP Coil System Benchmark BMX96 System PX 400 MicroCatheter PX SLIM MicroCatheter Velocity MicroCatheter INDIGO® Aspiration System - INDIGO Link Penumbra High Flow Aspiration Tubing Indigo Aspiration System – Lightning Aspiration Tubing Penumbra System ACE Penumbra System Penumbra System MAX Penumbra Indigo System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2023-01-03
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2020-03-24
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2019-06-27
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2025-02-18
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2019-06-27
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2024-03-29
QJP Catheter, Percutaneous, Neurovasculature Cardiovascular Class 2 870.1250 2024-03-29
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2024-12-09
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2010-10-29
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2010-10-29
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2016-06-10
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2020-03-24
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2015-01-27
GWG Endoscope, Neurological Neurology Class 2 882.1480 2016-06-10
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2015-07-02
QJP Catheter, Percutaneous, Neurovasculature Cardiovascular Class 2 870.1250 2022-11-08
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2022-11-08
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 2015-01-27
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2025-11-21
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2012-10-16
HCG Device, Neurovascular Embolization Neurology Class 2 882.5950 2015-07-02
KRD Device, Vascular, For Promoting Embolization Cardiovascular Class 2 870.3300 2015-07-02
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
HCG Device, Neurovascular Embolization Neurology Class 2 882.5950 2018-05-07
KRD Device, Vascular, For Promoting Embolization Cardiovascular Class 2 870.3300 2018-05-07
GWG Endoscope, Neurological Neurology Class 2 882.1480 2017-10-04
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2012-10-16
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 2020-09-02
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2023-01-03
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2010-10-29
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2010-10-29
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2017-02-10
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2010-10-29
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2011-11-15
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 2005-04-19
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2018-08-22
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2020-09-02
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2009-10-06
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2007-12-14
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2024-03-18
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2021-05-20
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2017-02-10
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2024-09-26
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2024-12-12
QJP Catheter, Percutaneous, Neurovasculature Cardiovascular Class 2 870.1250 2024-12-12
JCX Apparatus, Suction, Ward Use, Portable, Ac-Powered General, Plastic Surgery Class 2 878.4780 2012-10-16
QEX Coronary Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2017-07-18
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2017-07-18
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2017-05-09
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2026-03-06
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2019-01-02
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2020-11-20
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2024-06-27
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 2016-07-25
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 2021-03-01
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
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2021-07-12
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2008-01-15
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2022-08-24
QJP Catheter, Percutaneous, Neurovasculature Cardiovascular Class 2 870.1250 2022-08-24
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2018-10-06
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 2019-03-18
QEX Coronary Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2019-03-18
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2018-08-13
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2014-01-21
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
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2020-06-11
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2010-10-29
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2026-04-28
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2015-10-15
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2020-09-02
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2016-06-10
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2016-06-10
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2024-09-24

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
3013758550 Penumbra Inc. Livermore, CA, US
3005168196 PENUMBRA, INC. Alameda, 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
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
K192036 Inari Medical ClotTriever Thrombectomy System 2019-08-29

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-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.
Z-0009-2024 Boston Scientific Corporation 2
Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac guide catheter
Z-0010-04 Bard Peripheral Vascular 2
Conquest Balloon Dilation Catheters Model/Catalog Number CQ 75124
Z-0010-2024 Boston Scientific Corporation 2
Guider Softip Guide Catheter 7F PRE-SHAPED 40 90CM, Catalog number H965100430, cardiac guide catheter

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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 3016591327. Last updated year: 2026. Please use registration number 3016591327 when referencing this establishment in official correspondence.
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