FDA 510(k) Applications Submitted by PENUMBRA, INC.
FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
K190719 |
03/20/2019 |
Artemis Eye System |
Penumbra, Inc. |
K170852 |
03/22/2017 |
POD Packing Coil |
Penumbra, Inc. |
K161523 |
06/02/2016 |
INDIGO Aspiration System |
Penumbra, Inc. |
K173614 |
11/22/2017 |
Penumbra Coil 400, Ruby Coil System, POD System |
Penumbra, Inc. |
K203440 |
11/23/2020 |
Penumbra System (Reperfusion Catheter RED 62) |
Penumbra, Inc. |
K202251 |
08/10/2020 |
Penumbra System (Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology; Penumbra JET 7MAX) |
Penumbra, Inc. |
K192955 |
10/21/2019 |
Penumbra LP Coil System |
Penumbra, Inc. |
K212838 |
09/07/2021 |
Benchmark Intracranial Access System |
Penumbra, Inc. |
K213390 |
10/15/2021 |
Benchmark BMX96 Access System |
Penumbra, Inc. |
K160832 |
03/25/2016 |
Penumbra Smart Coil |
PENUMBRA, INC. |
K161064 |
04/15/2016 |
Penumbra System ACE 68 Reperfusion Catheter |
Penumbra, Inc. |
K141134 |
05/01/2014 |
POD SYSTEM |
PENUMBRA, INC. |
K151572 |
06/11/2015 |
Penumbra Smart Coil |
PENUMBRA, INC. |
K161640 |
06/14/2016 |
Penumbra System ACE 68 Reperfusion Catheter |
Penumbra, Inc. |
K152840 |
09/29/2015 |
Lantern Delivery Microcatheter |
PENUMBRA, INC. |
K143218 |
11/10/2014 |
Penumbra Smart Coil |
Penumbra, Inc. |
K222358 |
08/04/2022 |
Indigo Aspiration System - Lightning Flash |
Penumbra, Inc. |
K223186 |
10/12/2022 |
Indigo« Aspiration System û Lightning Bolt Aspiration Tubing |
Penumbra, Inc. |
K190464 |
02/26/2019 |
Penumbra System 3D Revascularization Device |
Penumbra, Inc. |
K120330 |
02/02/2012 |
PENUMBRA COIL SYSTEM/PENUMBRA COIL 400 |
PENUMBRA, INC. |
K090752 |
03/20/2009 |
PENUMBRA SYSTEM (PENNUMBRA REPERFUSION CATHETER 054), MODEL PSC054; (PENUMBRA SEPARATOR 054), MODEL PSS054 |
PENUMBRA, INC. |
K171332 |
05/08/2017 |
Artemis Neuro Evacuation Device |
Penumbra, Inc. |
K152699 |
09/21/2015 |
Apollo System |
PENUMBRA, INC. |
K183296 |
11/27/2018 |
REAL Immersive System |
Penumbra, Inc. |
K201271 |
05/12/2020 |
Benchmark BMX96 Access System |
Penumbra, Inc. |
K190010 |
01/03/2019 |
Penumbra System Reperfusion Catheter JET 7 |
Penumbra, Inc. |
K210323 |
02/04/2021 |
Indigo Aspiration System - Lightning Aspiration Tubing |
Penumbra, Inc. |
K200771 |
03/25/2020 |
Indigo Aspiration System Lightning Aspiration Tubing |
Penumbra, Inc. |
K211411 |
05/06/2021 |
Penumbra System (RED 68 Reperfusion Catheter) |
Penumbra, Inc. |
K191946 |
07/22/2019 |
Penumbra System Penumbra JET 7X |
Penumbra, Inc. |
K182522 |
09/13/2018 |
Penumbra System (Modified 110 Aspiration Tubing) |
Penumbra, Inc. |
K222808 |
09/16/2022 |
Penumbra System (Reperfusion Catheter RED 43) |
Penumbra, Inc. |
K193244 |
11/25/2019 |
Indigo Aspiration System û Lightning Aspiration Tubing |
Penumbra, Inc. |
K142870 |
10/01/2014 |
Penumbra Embolectomy Aspiration System [INDIGO Aspiration System] |
PENUMBRA, INC. |
K100769 |
03/18/2010 |
PENUMBRA SYSTEM SEPARATOR FLEX (026,032,041,054), MODELS PSF026, PSF032, PSF041, PSF054 |
PENUMBRA, INC. |
K111380 |
05/16/2011 |
NEURON MAX SYSTEM |
PENUMBRA, INC. |
K151623 |
06/16/2015 |
Penumbra System 110 Aspiration Tubing |
Penumbra, Inc. |
K121917 |
07/02/2012 |
PENUMBRA EMBOLECTOMY ASPIRATION SYSTEM |
PENUMBRA, INC. |
K142321 |
08/19/2014 |
Benchmark Intracranial Access System |
PENUMBRA, INC. |
K142458 |
09/02/2014 |
Penumbra System ACE |
PENUMBRA, INC. |
K152541 |
09/04/2015 |
Penumbra System ACE 64 and ACE 68 Reperfusion Catheters |
PENUMBRA, INC. |
K202821 |
09/24/2020 |
Indigo Aspiration System - Aspiration Catheter 12 and Separator 12 |
Penumbra, Inc. |
K162901 |
10/17/2016 |
Penumbra 3D Revascularization Device |
Penumbra, Inc. |
K173761 |
12/11/2017 |
Penumbra System Reperfusion Catheter JET 7 |
Penumbra, Inc. |
K211654 |
05/28/2021 |
Penumbra System (Reperfusion Catheter RED 72) |
Penumbra, Inc. |
K180008 |
01/02/2018 |
Penumbra System |
Penumbra, Inc. |
K180105 |
01/16/2018 |
Indigo Aspiration System - Penumbra Engine Pump, Indigo Aspiration System - Penumbra Engine Pump Canister |
Penumbra, Inc. |
K180412 |
02/15/2018 |
Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump and Canister |
Penumbra, Inc. |
K160449 |
02/18/2016 |
Penumbra System, Penumbra Pump MAX |
PENUMBRA, INC. |
K160533 |
02/18/2016 |
Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System) |
PENUMBRA, INC. |
K180939 |
04/10/2018 |
Indigo Aspiration System - Modified 110 Aspiration Tubing |
Penumbra, Inc. |
K161506 |
06/01/2016 |
Penumbra Aspiration System |
Penumbra, Inc. |
K163618 |
12/22/2016 |
INDIGO Aspiration System |
PENUMBRA, INC. |
K122756 |
09/07/2012 |
PENUMBRA PUMP MAX (110VAC), PENUMBRA PUMP MAX (230VAC), PENUMBAR PUMP MAX CANISTER/TUBING |
PENUMBRA, INC. |
K122772 |
09/10/2012 |
PENUMBRA DDC CATHETERS |
PENUMBRA, INC. |
K132931 |
09/18/2013 |
APOLLO SYSTEM |
PENUMBRA, INC. |
K113163 |
10/26/2011 |
PENUMBRA SYSTEM MAX |
PENUMBRA, INC. |
K133317 |
10/28/2013 |
PENUMBRA SYSTEM / PENUMBRA SYSTEM MAX |
PENUMBRA, INC. |
K100826 |
03/24/2010 |
PENUMBRA CATHERER 025 |
PENUMBRA, INC. |
K103305 |
11/09/2010 |
PENUMBRA EMBOLIZATION COIL SYSTEM |
PENUMBRA, INC. |
K093970 |
12/23/2009 |
PICA CATHETER |
PENUMBRA, INC. |
K220683 |
03/08/2022 |
INDIGO Aspiration System (CAT RX Aspiration Catheter and Separator 4) |
Penumbra, Inc. |
K210083 |
01/12/2021 |
Indigo System Aspiration Catheter 7, Indigo Aspiration System Separator 7, Lightning 7 |
Penumbra, Inc. |
K192833 |
10/02/2019 |
Indigo Aspiration System |
Penumbra, Inc. |
K193595 |
12/23/2019 |
Indigo Aspiration System - Aspiration Catheter 7 and Separator 7 |
Penumbra, Inc. |
K070970 |
04/06/2007 |
NEURON SUPPORT CATHETER SYSTEM, MODEL 5F/6F |
PENUMBRA, INC. |
K082290 |
08/11/2008 |
NEURON DELIVERY CATHETER 070 |
PENUMBRA, INC. |
K072718 |
09/25/2007 |
PENUMBRA SYSTEM |
PENUMBRA, INC. |
K083125 |
10/22/2008 |
NEURON SELECT CATHETER SIZE 070 |
PENUMBRA, INC. |
K053491 |
12/15/2005 |
PENUMBRA BALLOON GUIDE CATHETER, MODEL 7.5F |
PENUMBRA, INC. |
K051758 |
06/29/2005 |
PENUMBRA ASPIRATION PUMP, MODEL 115V |
PENUMBRA, INC. |
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