Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015615738

FEI Number

3015615738

Entity Name

Penumbra Inc.

City/State/Country

Salt Lake City, UT, US

Establishment Address

1070 SOUTH 3800 WEST, SUITE 500, Salt Lake City, UT 84104, 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

Expiration Date (Year)

2026

510(k) Number

K203440

PMA Number

N/A

All Registered Proprietary Names

Penumbra System® (Reperfusion Catheter RED 43) INDIGO Aspiration System (CAT RX Aspiration Catheter and Separator 4) Element Vascular Access System Indigo® Aspiration System - Aspiration Catheter 12 and Separator 12 Indigo Lightning Flash Aspiration System - Select + Catheter Penumbra Engine Pump INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK Penumbra Indigo System Benchmark System Indigo® Aspiration System Lightning® Flash MIDWAY Delivery Catheter (MIDWAY 43 Delivery Catheter; MIDWAY 62 Delivery Catheter) Penumbra System (Reperfusion Catheter RED 72) Penumbra System MAX Penumbra Apollo System Penumbra System ACE 68 Reperfusion Catheter Penumbra LP Coil System Penumbra Coil System PC 400 Ruby Coil System Ruby XL System Neuron Intracranial Access System Penumbra Smart Coil System Penumbra Aspiration System Penumbra System Indigo® Aspiration System Lightning® Flash Aspiration Tubing Indigo® Aspiration System Lightning® Bolt Aspiration Tubing Penumbra System Engine Pump Indigo® Aspiration System - Aspiration Catheter 12 and Separator 12 Penumbra System ACE Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology Neuron Select Catheter Neuron Delivery Catheter Penumbra Indigo System Penumbra 3D Revascularization Device Indigo Aspiration System - Lightning Flash POD System JET7Reperfusion Catheter with MAX Delivery Device (JET7MAX) CAT Rx Indigo® Aspiration System Lightning Bolt Aspiration Tubing Penumbra System ACE 68 Reperfusion Catheter POD Packing Coil Benchmark BMX96 Access System Penumbra System Neuron MAX Penumbra DDC Catheters Indigo System Access25 Delivery Microcatheter Indigo Aspiration System - Aspiration Catheter 7, Separator 7, Lighnting 7 Indigo Aspiration System Lightning Aspiration Tubing Indigo Aspiration System - Aspiration Catheter 7 and Separator 7 Penumbra System (Reperfusion Catheter RED 72) Penumbra Separator 054 Penumbra Reperfusion Catheter 054 Penumbra System (RED 68 Reperfusion Catheter) Penumbra System (Thunderbolt Aspiration Tubing) Smart Coil BMX 81 Delivery Catheter Artemis Neuro Evacuation Device Penumbra High Flow Aspiration Tubing PX 400 MicroCatheter PX SLIM MicroCatheter Velocity MicroCatheter Indigo Aspiration System Lightning Aspiration Tubing Penumbra ACE System Benchmark Intracranial Access System Penumbra Indigo System Penumbra System MAX Indigo System INDIGO® Aspiration System - INDIGO Link ASPIRATION PUMP Penumbra POD Embolization Coil Penumbra Ruby Embolization Coil Penumbra PC400 Embolization Coil Reperfusion Catheter RED 62

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
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
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2024-12-09
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	2024-06-27
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	2026-03-06
QEW	Peripheral Mechanical Thrombectomy With Aspiration	Cardiovascular	Class 2	870.5150	2018-05-09
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2015-01-27
QEW	Peripheral Mechanical Thrombectomy With Aspiration	Cardiovascular	Class 2	870.5150	2023-01-03
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2024-03-29
QJP	Catheter, Percutaneous, Neurovasculature	Cardiovascular	Class 2	870.1250	2024-03-29
NRY	Catheter, Thrombus Retriever	Cardiovascular	Class 2	870.1250	2021-08-19
NRY	Catheter, Thrombus Retriever	Cardiovascular	Class 2	870.1250	2024-11-13
NRY	Catheter, Thrombus Retriever	Cardiovascular	Class 2	870.1250	2012-10-16
GWG	Endoscope, Neurological	Neurology	Class 2	882.1480	2016-06-10
NRY	Catheter, Thrombus Retriever	Cardiovascular	Class 2	870.1250	2017-02-10
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	2011-11-15
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2011-11-15
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2025-03-21
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2010-10-29
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
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
NRY	Catheter, Thrombus Retriever	Cardiovascular	Class 2	870.1250	2010-10-29
QEW	Peripheral Mechanical Thrombectomy With Aspiration	Cardiovascular	Class 2	870.5150	2025-11-21
NRY	Catheter, Thrombus Retriever	Cardiovascular	Class 2	870.1250	2018-08-13
QEW	Peripheral Mechanical Thrombectomy With Aspiration	Cardiovascular	Class 2	870.5150	2020-11-20
NRY	Catheter, Thrombus Retriever	Cardiovascular	Class 2	870.1250	2016-06-10
NRY	Catheter, Thrombus Retriever	Cardiovascular	Class 2	870.1250	2020-09-02
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2007-12-14
QEW	Peripheral Mechanical Thrombectomy With Aspiration	Cardiovascular	Class 2	870.5150	2016-06-10
NRY	Catheter, Thrombus Retriever	Cardiovascular	Class 2	870.1250	2017-05-09
QEW	Peripheral Mechanical Thrombectomy With Aspiration	Cardiovascular	Class 2	870.5150	2024-03-18
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
NRY	Catheter, Thrombus Retriever	Cardiovascular	Class 2	870.1250	2020-03-24
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
QEW	Peripheral Mechanical Thrombectomy With Aspiration	Cardiovascular	Class 2	870.5150	2023-02-17
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
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
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2022-08-24
QJP	Catheter, Percutaneous, Neurovasculature	Cardiovascular	Class 2	870.1250	2022-08-24
NRY	Catheter, Thrombus Retriever	Cardiovascular	Class 2	870.1250	2019-01-02
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2011-11-15
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2014-01-21
QEW	Peripheral Mechanical Thrombectomy With Aspiration	Cardiovascular	Class 2	870.5150	2012-10-16
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2024-12-12
QJP	Catheter, Percutaneous, Neurovasculature	Cardiovascular	Class 2	870.1250	2024-12-12
QEW	Peripheral Mechanical Thrombectomy With Aspiration	Cardiovascular	Class 2	870.5150	2021-02-10
QEW	Peripheral Mechanical Thrombectomy With Aspiration	Cardiovascular	Class 2	870.5150	2020-03-24
QEW	Peripheral Mechanical Thrombectomy With Aspiration	Cardiovascular	Class 2	870.5150	2020-09-02
NRY	Catheter, Thrombus Retriever	Cardiovascular	Class 2	870.1250	2019-06-27
NRY	Catheter, Thrombus Retriever	Cardiovascular	Class 2	870.1250	2025-02-18
QEW	Peripheral Mechanical Thrombectomy With Aspiration	Cardiovascular	Class 2	870.5150	2024-09-24
NRY	Catheter, Thrombus Retriever	Cardiovascular	Class 2	870.1250	2009-10-06
NRY	Catheter, Thrombus Retriever	Cardiovascular	Class 2	870.1250	2021-07-12
NRY	Catheter, Thrombus Retriever	Cardiovascular	Class 2	870.1250	2026-06-11
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
QJP	Catheter, Percutaneous, Neurovasculature	Cardiovascular	Class 2	870.1250	2022-11-08
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2022-11-08
GWG	Endoscope, Neurological	Neurology	Class 2	882.1480	2017-10-04
NRY	Catheter, Thrombus Retriever	Cardiovascular	Class 2	870.1250	2015-10-15
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2010-10-29
QEW	Peripheral Mechanical Thrombectomy With Aspiration	Cardiovascular	Class 2	870.5150	2021-03-01
NRY	Catheter, Thrombus Retriever	Cardiovascular	Class 2	870.1250	2015-07-02
QJP	Catheter, Percutaneous, Neurovasculature	Cardiovascular	Class 2	870.1250	2022-08-24
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2022-08-24
QEW	Peripheral Mechanical Thrombectomy With Aspiration	Cardiovascular	Class 2	870.5150	2016-07-25
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2019-07-12
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2019-07-12
NRY	Catheter, Thrombus Retriever	Cardiovascular	Class 2	870.1250	2015-01-27
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	2026-04-28
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
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
NRY	Catheter, Thrombus Retriever	Cardiovascular	Class 2	870.1250	2021-05-20

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
3005168196	PENUMBRA, INC.	Alameda, CA, 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-0783-2020	Abbott Medical	2	Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303
Z-0789-2020	Abbott Medical	2	Fast-Cath Hemostasis Introducer, HEMOSTASIS INTRODUCER, 8.5F, 2.83 mm, REF 406143 - Product Usage: The Fast-Cath Hemostasis Introducers are indicated for the introduction of angiographic catheters, closed-end catheters, balloon catheters, and electrodes into a vessel where minimizing blood loss is essential.
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015615738. Last updated year: 2026. Please use registration number 3015615738 when referencing this establishment in official correspondence.