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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