Penumbra, Inc. - FDA 510(k) Cleared Devices
86
Total
84
Cleared
0
Denied
86 devices
Cleared
Nov 18, 2020
Indigo Aspiration System - Aspiration Catheter 12 and Separator 12
Cardiovascular
55d
Cleared
Aug 31, 2020
Penumbra System (Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology
Neurology
21d
Cleared
Aug 19, 2020
Indigo Aspiration System - Aspiration Catheter 7 and Separator 7
Cardiovascular
240d
Cleared
Jun 11, 2020
Benchmark BMX96 Access System
Neurology
30d
Cleared
May 28, 2020
Indigo System Aspiration Catheter 12, Indigo Aspiration System Separator 12
Cardiovascular
217d
Cleared
CT
Apr 22, 2020
Indigo Aspiration System Lightning Aspiration Tubing
Cardiovascular
28d
Cleared
CT
Mar 13, 2020
Indigo Aspiration System – Lightning Aspiration Tubing
Cardiovascular
109d
Cleared
Feb 27, 2020
Penumbra System Penumbra JET 7X
Neurology
220d
Cleared
CT
Dec 20, 2019
Indigo Aspiration System
Cardiovascular
79d
Cleared
Nov 20, 2019
Penumbra LP Coil System
Neurology
30d
Cleared
Aug 30, 2019
Artemis Eye System
Neurology
163d
Cleared
Jun 16, 2019
Penumbra System Reperfusion Catheter JET 7
Neurology
164d
Cleared
Apr 26, 2019
Penumbra System 3D Revascularization Device
Neurology
59d
Cleared
Mar 18, 2019
REAL Immersive System
Physical Medicine
111d
Cleared
Oct 12, 2018
Penumbra System (Modified 110 Aspiration Tubing)
Neurology
29d
Cleared
Aug 17, 2018
Penumbra System Reperfusion Catheter JET 7
Neurology
249d
Cleared
Jun 20, 2018
Penumbra System
Neurology
169d
Cleared
May 15, 2018
Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump and...
Cardiovascular
89d
Cleared
May 03, 2018
Indigo Aspiration System - Modified 110 Aspiration Tubing
Cardiovascular
23d
Cleared
Apr 17, 2018
Penumbra Coil 400, Ruby Coil System, POD System
Neurology
146d
Cleared
Mar 08, 2018
Indigo Aspiration System - Penumbra Engine Pump, Indigo Aspiration System -...
Cardiovascular
51d
Cleared
Aug 14, 2017
Artemis Neuro Evacuation Device
Neurology
98d
Cleared
Jul 19, 2017
POD Packing Coil
Neurology
119d
Cleared
May 24, 2017
INDIGO Aspiration System
Cardiovascular
153d
Cleared
CT
Apr 20, 2017
Penumbra 3D Revascularization Device
Neurology
185d
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