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PENUMBRA, INC.

United States·US-MF-000008514

Last updated September 17, 2026

Information

Country: United States
Address: One Penumbra Place, Alameda, United States
Website: penumbrainc.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Mary Rose
EUDAMED SRN: US-MF-000008514
FDA FEI Number: 3013758550
DUNS Number: 191077671

Catalogue (1506)

Page 29 of 31

Device	Model / Reference	Registries	Class	Status
Benchmark MAX System	BMX7F105-A	FDA UDI	Class II	Active
PX SLIM Delivery Microcatheter	PXSLIM045-B	FDA UDI	Class II	Active
Benchmark MAX System	BMX9680-A	FDA UDI	Class II	Active
Swift Coil System	400SWPC08-A	FDA UDI	Class II	Active
Benchmark MAX System	BMX96100H1125-A	FDA UDI	Class II	Active
Benchmark MAX System	BMX96100MSIMV125-A	FDA UDI	Class II	Active
Swift Coil System	SDH1-A	FDA UDI	Class II	Active
Benchmark MAX System	BMX7F95-A	FDA UDI	Class II	Active
Lantern Delivery Catheter	PXSLIMLAN135T45	FDA UDI	Class II	Active
Swift Coil System	400SWPC04-A	FDA UDI	Class II	Active
PX SLIM 150 cm, 45° tip	PXSLIM045	EUDAMEDFDA UDI	Class III	Active
Penumbra Smart Coil Wave Extra Soft, 1 mm x 1 cm	400SMTHXSFT0101	EUDAMEDFDA UDI	Class III	Active
Artemis Neuro Evacuation Device 1.5 mm	AP15	EUDAMED	Class III	Active
Penumbra System (Reperfusion Catheter RED 72)	K242104	FDA 510(k)	Class II	Active
Indigo Aspiration System - Lightning Flash	K222358	FDA 510(k)	Class II	Active
Indigo Aspiration System Lightning Aspiration Tubing	K200771	FDA 510(k)	Class II	Active
Indigo Aspiration System	K192833	FDA 510(k)	Class II	Active
Apollo System	K132931	FDA 510(k)	Class II	Active
Indigo® Aspiration System - Lightning® Flash	K240030	FDA 510(k)	Class II	Active
Indigo System Aspiration Catheter 12, Indigo Aspiration System Separator 12	K192981	FDA 510(k)	Class II	Active
Indigo Aspiration System - Aspiration Catheter 7 and Separator 7	K193595	FDA 510(k)	Class II	Active
Penumbra System 3D Revascularization Device	K190464	FDA 510(k)	Class II	Active
INDIGO Aspiration System (CAT RX Aspiration Catheter and Separator 4)	K220683	FDA 510(k)	Class II	Active
Benchmark Intracranial Access System	K142321	FDA 510(k)	Class II	Active
Indigo Aspiration System - Modified 110 Aspiration Tubing	K180939	FDA 510(k)	Class II	Active
Penumbra System Max	K113163	FDA 510(k)	Class II	Active
Penumbra System ACE 68 Reperfusion Catheter	K161640	FDA 510(k)	Class II	Active
Penumbra System (pennumbra Reperfusion Catheter 054), Model Psc054; (penumbra Separator 054), Model Pss054	K090752	FDA 510(k)	Class II	Active
Indigo® Lightning Flash Aspiration System – Select +™ Catheter	K241399	FDA 510(k)	Class II	Active
Penumbra Embolectomy Aspiration System	K121917	FDA 510(k)	Class II	Active
Penumbra System (Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology; Penumbra JET 7MAX)	K202251	FDA 510(k)	Class II	Active
Indigo® Aspiration System – Aspiration Catheter 6X	K242319	FDA 510(k)	Class II	Active
Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump and Canister	K180412	FDA 510(k)	Class II	Active
Penumbra System Separator Flex (026, 032, 041, 054), Models Psf026, Psf032, Psf041, Psf054	K100769	FDA 510(k)	Class II	Active
Penumbra Embolization Coil System	K103305	FDA 510(k)	Class II	Active
Element Vascular Access System	K242520	FDA 510(k)	Class II	Active
Penumbra System Penumbra JET 7X	K191946	FDA 510(k)	Class II	Active
Penumbra Coil System/Penumbra Coil 400	K120330	FDA 510(k)	Class II	Active
Indigo Aspiration System – Lightning Aspiration Tubing	K193244	FDA 510(k)	Class II	Active
INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK	K251949	FDA 510(k)	Class II	Active
Ruby XL System	K250079	FDA 510(k)	Class II	Active
Indigo® Aspiration System – Lightning Bolt Aspiration Tubing	K223186	FDA 510(k)	Class II	Active
Penumbra System ACE 64 and ACE 68 Reperfusion Catheters	K152541	FDA 510(k)	Class II	Active
Penumbra LP Coil System	K230284	FDA 510(k)	Class II	Active
Penumbra System (Reperfusion Catheter RED 43)	K222808	FDA 510(k)	Class II	Active
Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System)	K160533	FDA 510(k)	Class II	Active
Penumbra System (Reperfusion Catheter RED 62)	K203440	FDA 510(k)	Class II	Active
Penumbra Smart Coil	K143218	FDA 510(k)	Class II	Active
Penumbra Balloon Guide Catheter, Model 7.5f	K053491	FDA 510(k)	Class II	Active
Penumbra System / Penumbra System Max	K133317	FDA 510(k)	Class II	Active

Related Companies

Authorised Representatives

Penumbra Europe GmbH DE

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (10)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Dec 15, 2020	Z-0848-2021	—	terminated	The catheter may become susceptible to distal tip damage during use. Distal tip damage in conjunction with pressurization of contrast injection may result in potential vessel damage, and subsequent patient injury or death.
Dec 15, 2020	Z-0851-2021	—	terminated	The catheter may become susceptible to distal tip damage during use. Distal tip damage in conjunction with pressurization of contrast injection may result in potential vessel damage, and subsequent patient injury or death.
Dec 15, 2020	Z-0850-2021	—	terminated	The catheter may become susceptible to distal tip damage during use. Distal tip damage in conjunction with pressurization of contrast injection may result in potential vessel damage, and subsequent patient injury or death.
Dec 15, 2020	Z-0849-2021	—	terminated	The catheter may become susceptible to distal tip damage during use. Distal tip damage in conjunction with pressurization of contrast injection may result in potential vessel damage, and subsequent patient injury or death.
Jun 9, 2017	Z-2702-2017	—	terminated	Penumbra has identified an issue in these four lots involving a raw material component of the delivery wire. This issue could result in breakage of the delivery wire, which could potentially lead to serious patient injury or death.
Mar 4, 2011	Z-1906-2011	—	terminated	The diameter of a component of the device is out of tolerance specification; the Delivery Pusher pull wire which secures the coil in place can prolapse and allow premature detachment of the coil.
Oct 25, 2010	Z-0428-2011	—	terminated	Reperfusion catheter may fail at the mid-shaft joint and may break off. If the segment cannot be removed, it may result in blocked blood flow, requiring emergency medical treatment.
Sep 22, 2009	Z-0001-2010	—	terminated	Failure-- product can kink or ovalize, which may result in difficulty in catheter advancement or delivery of other devices and damage to catheter, which could lead to patient injury or death as a result of portions being retained in the patient.
Jul 2, 2009	Z-2049-2009	—	terminated	Leakage-- Due to a manufacturing error, some products may have a fold in the innermost layer, causing disruption in the layering process and may result in blow holds or exposed wire braids, which may result in further damage.
Jul 1, 2009	Z-2313-2009	—	terminated	Misbranding--Some products may be identified with the wrong ID band content 'Neuron 6F 070' instead of 'Neuron 6F delivery'

FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

Penumbra Inc. Roseville, CA · US FEI 3016591327