Penumbra, Inc. - FDA 510(k) Cleared Devices
85
Total
83
Cleared
0
Denied
44 devices
Cleared
Jul 12, 2016
Penumbra System ACE 68 Reperfusion Catheter
Neurology
28d
Cleared
Jun 12, 2016
Penumbra System ACE 68 Reperfusion Catheter
Neurology
58d
Cleared
May 25, 2016
Penumbra System, Penumbra Pump MAX
Neurology
97d
Cleared
Apr 20, 2016
Penumbra Smart Coil
Neurology
26d
Cleared
Mar 17, 2016
Apollo System
Neurology
178d
Cleared
Jan 13, 2016
Penumbra System ACE 64 and ACE 68 Reperfusion Catheters
Neurology
131d
Cleared
Aug 06, 2015
Penumbra System 110 Aspiration Tubing
Neurology
51d
Cleared
Jul 10, 2015
Penumbra Smart Coil
Neurology
29d
Cleared
May 22, 2015
Penumbra System ACE
Neurology
262d
Cleared
Mar 18, 2015
Penumbra Smart Coil
Neurology
128d
Cleared
Jul 03, 2014
POD SYSTEM
Neurology
63d
Cleared
May 13, 2014
PENUMBRA SYSTEM / PENUMBRA SYSTEM MAX
Neurology
197d
Cleared
Jan 17, 2014
APOLLO SYSTEM
Neurology
121d
Cleared
Apr 02, 2012
PENUMBRA COIL SYSTEM/PENUMBRA COIL 400
Neurology
60d
Cleared
Nov 23, 2011
PENUMBRA SYSTEM MAX
Neurology
28d
Cleared
Jan 26, 2011
PENUMBRA EMBOLIZATION COIL SYSTEM
Neurology
78d
Cleared
May 21, 2010
PENUMBRA SYSTEM SEPARATOR FLEX (026,032,041,054), MODELS PSF026, PSF032,...
Neurology
64d
Cleared
Sep 21, 2009
PENUMBRA SYSTEM (PENNUMBRA REPERFUSION CATHETER 054), MODEL PSC054
Neurology
185d
Cleared
Dec 28, 2007
PENUMBRA SYSTEM
Neurology
94d