Penumbra, Inc. - FDA 510(k) Cleared Devices
86
Total
84
Cleared
0
Denied
86 devices
Cleared
Sep 26, 2016
Penumbra Aspiration System
Cardiovascular
117d
Cleared
Jul 12, 2016
Penumbra System ACE 68 Reperfusion Catheter
Neurology
28d
Cleared
Jul 01, 2016
INDIGO Aspiration System
Cardiovascular
29d
Cleared
Jun 12, 2016
Penumbra System ACE 68 Reperfusion Catheter
Neurology
58d
Cleared
May 25, 2016
Penumbra System, Penumbra Pump MAX
Neurology
97d
Cleared
May 24, 2016
Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System)
Cardiovascular
96d
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
Dec 02, 2015
Lantern Delivery Microcatheter
Cardiovascular
64d
Cleared
Aug 06, 2015
Penumbra System 110 Aspiration Tubing
Neurology
51d
Cleared
Jul 10, 2015
Penumbra Smart Coil
Neurology
29d
Cleared
May 26, 2015
Penumbra Embolectomy Aspiration System [INDIGO Aspiration System]
Cardiovascular
237d
Cleared
May 22, 2015
Penumbra System ACE
Neurology
262d
Cleared
Mar 18, 2015
Penumbra Smart Coil
Neurology
128d
Cleared
Jan 26, 2015
Benchmark Intracranial Access System
Cardiovascular
160d
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
Nov 20, 2012
PENUMBRA DDC CATHETERS
Cardiovascular
71d
Cleared
Oct 02, 2012
PENUMBRA PUMP MAX (110VAC), PENUMBRA PUMP MAX (230VAC), PENUMBAR PUMP MAX...
General & Plastic Surgery
25d
Cleared
Sep 19, 2012
PENUMBRA EMBOLECTOMY ASPIRATION SYSTEM
Cardiovascular
79d
Cleared
Apr 02, 2012
PENUMBRA COIL SYSTEM/PENUMBRA COIL 400
Neurology
60d
Cleared
Nov 23, 2011
PENUMBRA SYSTEM MAX
Neurology
28d
Cleared
Jul 19, 2011
NEURON MAX SYSTEM
Cardiovascular
64d
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