PENUMBRA, INC.

Entity profile compiled from public source records

Public Record Profile Registrations: 4 510(k) filings: 0 Recalls: 1

Known Identifiers & Locations

FEI Numbers 3005168196, 3013758550, 3015615738, 3016591327
Owner Operator Numbers 9072336
Locations Covered Alameda, CA, US; Livermore, CA, US; Roseville, CA, US; Salt Lake City, UT, US

Registered Establishments (4)

Registration # Establishment Name Location Establishment Type(s) Action
3005168196 PENUMBRA, INC. Alameda, CA, US Manufacture Medical Device View Details
3013758550 Penumbra Inc. Livermore, CA, US Manufacture Medical Device View Details
3015615738 Penumbra Inc. Salt Lake City, UT, US Manufacture Medical Device View Details
3016591327 Penumbra Inc. Roseville, CA, US Manufacture Medical Device View Details

510(k) Premarket Notifications (0)

No 510(k) notifications found for this entity.

FDA Recall History (1)

Recall # Product Description Initiation Date Status Action
Z-0001-2010 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. Reason: 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. 2009-09-22 Terminated View Details

Profile Disclaimer

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