Medical Device Manufacturer · US , Alameda , CA

Penumbra, Inc. - FDA 510(k) Cleared Devices

86 submissions · 84 cleared · Since 2005

Official Website

86

Total

84

Cleared

0

Denied

86 devices

76-86 of 86

Cleared Jan 26, 2011

PENUMBRA EMBOLIZATION COIL SYSTEM

Neurology · 78d

Cleared Jul 13, 2010

PENUMBRA CATHERER 025

Cardiovascular · 111d

Cleared May 21, 2010

PENUMBRA SYSTEM SEPARATOR FLEX (026,032,041,054), MODELS PSF026, PSF032,...

Neurology · 64d

Cleared Jan 15, 2010

Cardiovascular · 23d

Cleared Sep 21, 2009

PENUMBRA SYSTEM (PENNUMBRA REPERFUSION CATHETER 054), MODEL PSC054

Neurology · 185d

Cleared Nov 21, 2008

NEURON SELECT CATHETER SIZE 070

Cardiovascular · 30d

Cleared Oct 31, 2008

NEURON DELIVERY CATHETER 070

Cardiovascular · 81d

Cleared Dec 28, 2007

PENUMBRA SYSTEM

Neurology · 94d

Cleared Aug 17, 2007

NEURON SUPPORT CATHETER SYSTEM, MODEL 5F/6F

Cardiovascular · 133d

Cleared Apr 27, 2006

PENUMBRA BALLOON GUIDE CATHETER, MODEL 7.5F

Cardiovascular · 133d

Cleared Aug 17, 2005

PENUMBRA ASPIRATION PUMP, MODEL 115V

General & Plastic Surgery · 49d

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