Penumbra, Inc. - FDA 510(k) Cleared Devices
87
Total
85
Cleared
0
Denied
39 devices
Cleared
Jul 01, 2016
INDIGO Aspiration System
Cardiovascular
29d
Cleared
May 24, 2016
Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System)
Cardiovascular
96d
Cleared
Dec 02, 2015
Lantern Delivery Microcatheter
Cardiovascular
64d
Cleared
May 26, 2015
Penumbra Embolectomy Aspiration System [INDIGO Aspiration System]
Cardiovascular
237d
Cleared
Jan 26, 2015
Benchmark Intracranial Access System
Cardiovascular
160d
Cleared
Nov 20, 2012
PENUMBRA DDC CATHETERS
Cardiovascular
71d
Cleared
Sep 19, 2012
PENUMBRA EMBOLECTOMY ASPIRATION SYSTEM
Cardiovascular
79d
Cleared
Jul 19, 2011
NEURON MAX SYSTEM
Cardiovascular
64d
Cleared
Jul 13, 2010
PENUMBRA CATHERER 025
Cardiovascular
111d
Cleared
Jan 15, 2010
PICA CATHETER
Cardiovascular
23d
Cleared
Nov 21, 2008
NEURON SELECT CATHETER SIZE 070
Cardiovascular
30d
Cleared
Oct 31, 2008
NEURON DELIVERY CATHETER 070
Cardiovascular
81d
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