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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 30 of 31

Device	Model / Reference	Registries	Class	Status
Neuron Max System	K111380	FDA 510(k)	Class II	Active
Artemis Neuro Evacuation Device	K171332	FDA 510(k)	Class II	Active
Penumbra 3D Revascularization Device	K162901	FDA 510(k)	Class II	Active
REAL Immersive System	K183296	FDA 510(k)FDA UDI	Class II	Active
Indigo System Aspiration Catheter 7, Indigo Aspiration System Separator 7, Lightning 7	K210083	FDA 510(k)	Class II	Active
Penumbra System (Reperfusion Catheter RED 72)	K211654	FDA 510(k)	Class II	Active
Penumbra Smart Coil	K160832	FDA 510(k)	Class II	Active
Lantern Delivery Microcatheter	K152840	FDA 510(k)	Class II	Active
MIDWAY Delivery Catheter (MIDWAY 43 Delivery Catheter; MIDWAY 62 Delivery Catheter)	K233201	FDA 510(k)	Class II	Active
Indigo® Aspiration System – Lightning Bolt Aspiration Tubing	K242075	FDA 510(k)	Class II	Active
Penumbra System (Modified 110 Aspiration Tubing)	K182522	EUDAMEDFDA 510(k)FDA UDI	Class II	Active
Penumbra Coil 400, Ruby Coil System, POD System	K173614	FDA 510(k)	Class II	Active
INDIGO® Aspiration System – Lightning Flash Aspiration Tubing; INDIGO® Aspiration System – Lightning Bolt Aspiration Tubing	K252612	FDA 510(k)	Class II	Active
Penumbra Aspiration Pump, Model 115v	K051758	FDA 510(k)	Class II	Active
Penumbra System, Penumbra Pump MAX	K160449	FDA 510(k)	Class II	Active
Benchmark BMX96 Access System	K213390	FDA 510(k)	Class II	Active
Penumbra Pump Max (110vac), Penumbra Pump Max (230vac), Penumbar Pump Max Canister/Tubing	K122756	FDA 510(k)	Class II	Active
Indigo Aspiration System - Penumbra Engine Pump, Indigo Aspiration System - Penumbra Engine Pump Canister	K180105	FDA 510(k)	Class II	Active
Penumbra System ACE 68 Reperfusion Catheter	K161064	FDA 510(k)	Class II	Active
INDIGO Aspiration System	K163618	FDA 510(k)	Class II	Active
Neuron Select Catheter Size 070	K083125	FDA 510(k)	Class II	Active
INDIGO Aspiration System	K161523	FDA 510(k)	Class II	Active
Access25™ Delivery Microcatheter	K242033	FDA 510(k)	Class II	Active
Apollo System	K152699	FDA 510(k)	Class II	Active
Benchmark Intracranial Access System	K212838	FDA 510(k)	Class II	Active
Penumbra LP Coil System	K192955	FDA 510(k)	Class II	Active
Artemis Eye System	K190719	FDA 510(k)	Class II	Active
Penumbra System Reperfusion Catheter JET 7	K190010	FDA 510(k)	Class II	Active
Penumbra Catherer 025	K100826	FDA 510(k)	Class II	Active
Penumbra System Reperfusion Catheter JET 7	K173761	FDA 510(k)	Class II	Active
Penumbra System (RED 68 Reperfusion Catheter)	K211411	FDA 510(k)	Class II	Active
Neuron Delivery Catheter 070	K082290	FDA 510(k)	Class II	Active
Penumbra Smart Coil	K151572	FDA 510(k)	Class II	Active
Penumbra Aspiration System	K161506	FDA 510(k)	Class II	Active
INDIGO® Aspiration System – INDIGO Link	K260599	FDA 510(k)	Class II	Active
Penumbra System ACE	K142458	FDA 510(k)	Class II	Active
Benchmark BMX96 Access System	K201271	FDA 510(k)	Class II	Active
Pod System	K141134	FDA 510(k)	Class II	Active
Neuron Support Catheter System, Model 5f/6f	K070970	FDA 510(k)	Class II	Active
BENCHMARK BMX81 Access System	K221822	FDA 510(k)	Class II	Active
Indigo Aspiration System - Lightning Aspiration Tubing	K210323	FDA 510(k)	Class II	Active
Pica Catheter	K093970	FDA 510(k)	Class II	Active
Penumbra Embolectomy Aspiration System [INDIGO Aspiration System]	K142870	FDA 510(k)	Class II	Active
Indigo Aspiration System - Aspiration Catheter 12 and Separator 12	K202821	FDA 510(k)	Class II	Active
Penumbra System 110 Aspiration Tubing	K151623	FDA 510(k)	Class II	Active
POD Packing Coil	K170852	FDA 510(k)	Class II	Active
POD, 3 mm x 20 cm	RBYPOD3	EUDAMEDFDA UDI	Class III	Active
Penumbra ENGINE Pump	PMXENGN	EUDAMEDFDA UDI	Class IIa	Active
6F Benchmark 95cm Straight	BMK6F95	EUDAMEDFDA UDI	Class III	Active
Reperfusion Catheter 3MAX, 153 cm	3MAXC	EUDAMEDFDA UDI	Class III	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