FDA.report

PENUMBRA, INC.

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
30051681963005168196PENUMBRA, INC.1N2026-01-01One Penumbra Place Alameda CA US 94502

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
783881551910716K260599INDIGO® Aspiration System – INDIGO LinkQEW2026-04-24
783881181454493K252612INDIGO® Aspiration System – Lightning Flash Aspiration Tubing; INDIGO® Aspiration System – Lightning Bolt Aspiration TubingQEW2025-10-16
783881008436129K251949INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINKQEW2026-02-05
783882043486310K250079Ruby XL SystemKRD2025-03-14
783881572824930K242520Element Vascular Access SystemDYB2024-11-20
783881652142751K242319Indigo® Aspiration System – Aspiration Catheter 6XQEW2024-09-03
783881489797662K242104Penumbra System (Reperfusion Catheter RED 72)NRY2025-02-13
783881740942741K242075Indigo® Aspiration System – Lightning Bolt Aspiration TubingQEW2024-09-25
783881174938289K242033Access25™ Delivery MicrocatheterQJP2024-12-11
783881194484911K241399Indigo® Lightning Flash Aspiration System – Select +™ CatheterQEW2024-06-10
783881294333433K240030Indigo® Aspiration System - Lightning® FlashQEW2024-02-02
783881132657461K233201MIDWAY Delivery Catheter (MIDWAY 43 Delivery Catheter; MIDWAY 62 Delivery Catheter)QJP2024-03-27
783881383648886K230284Penumbra LP Coil SystemHCG2023-10-25
783881056585235K223186Indigo® Aspiration System – Lightning Bolt Aspiration TubingQEW2023-02-13
783881758888018K222808Penumbra System (Reperfusion Catheter RED 43)NRY2022-12-20
783881339396787K222358Indigo Aspiration System - Lightning FlashQEW2022-12-20
783881629638004K221822BENCHMARK BMX81 Access SystemQJP2022-11-04
783881914040107K220683INDIGO Aspiration System (CAT RX Aspiration Catheter and Separator 4)QEW2022-10-04
783881506977357K213390Benchmark BMX96 Access SystemQJP2022-08-18
783882044405334K212838Benchmark Intracranial Access SystemQJP2022-05-27
783881209199922K211654Penumbra System (Reperfusion Catheter RED 72)NRY2021-08-16
783881644891940K211411Penumbra System (RED 68 Reperfusion Catheter)NRY2021-07-01
783881970468153K210323Indigo Aspiration System - Lightning Aspiration TubingQEW2021-02-26
783881930904780K210083Indigo System Aspiration Catheter 7, Indigo Aspiration System Separator 7, Lightning 7QEW2021-02-09
783881603585411K203440Penumbra System (Reperfusion Catheter RED 62)NRY2021-05-20
783882073701803K202821Indigo Aspiration System - Aspiration Catheter 12 and Separator 12QEW2020-11-18
783881386440874K202251Penumbra System (Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology; Penumbra JET 7MAX)NRY2020-08-31
783881837281032K201271Benchmark BMX96 Access SystemDQY2020-06-11
783881230002469K200771Indigo Aspiration System Lightning Aspiration TubingQEW2020-04-22
783881196004931K193595Indigo Aspiration System - Aspiration Catheter 7 and Separator 7QEW2020-08-19
783881955955193K193244Indigo Aspiration System – Lightning Aspiration TubingQEW2020-03-13
783881831384577K192981Indigo System Aspiration Catheter 12, Indigo Aspiration System Separator 12QEW2020-05-28
783881020083565K192955Penumbra LP Coil SystemHCG2019-11-20
783881359823883K192833Indigo Aspiration SystemQEW2019-12-20
783881550865111K191946Penumbra System Penumbra JET 7XNRY2020-02-27
783882053866862K190719Artemis Eye SystemGWG2019-08-30
783881301233463K190464Penumbra System 3D Revascularization DeviceNRY2019-04-26
783881731483088K190010Penumbra System Reperfusion Catheter JET 7NRY2019-06-16
783881004659519K183296REAL Immersive SystemISD2019-03-18
783881099503699K182522Penumbra System (Modified 110 Aspiration Tubing)NRY2018-10-12
783882049252544K180939Indigo Aspiration System - Modified 110 Aspiration TubingQEW2018-05-03
783881876471731K180412Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump and CanisterQEW2018-05-15
783881491367691K180105Indigo Aspiration System - Penumbra Engine Pump, Indigo Aspiration System - Penumbra Engine Pump CanisterQEW2018-03-08
783881227574866K180008Penumbra SystemNRY2018-06-20
783881171584481K173761Penumbra System Reperfusion Catheter JET 7NRY2018-08-17
783881543323481K173614Penumbra Coil 400, Ruby Coil System, POD SystemHCG2018-04-17
783881630991140K171332Artemis Neuro Evacuation DeviceGWG2017-08-14
783881908767454K170852POD Packing CoilHCG2017-07-19
783881639425082K163618INDIGO Aspiration SystemQEX2017-05-24
783881998675143K162901Penumbra 3D Revascularization DeviceNRY2017-04-20
783881512842211K161640Penumbra System ACE 68 Reperfusion CatheterNRY2016-07-12
783881217102255K161523INDIGO Aspiration SystemQEW2016-07-01
783881599525000K161506Penumbra Aspiration SystemQEW2016-09-26
783881212230344K161064Penumbra System ACE 68 Reperfusion CatheterNRY2016-06-12
783881150697384K160832Penumbra Smart CoilHCG2016-04-20
783881250420454K160533Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System)QEW2016-05-24
783881106593225K160449Penumbra System, Penumbra Pump MAXNRY2016-05-25
783881786218427K152840Lantern Delivery MicrocatheterDQY2015-12-02
783881273424208K152699Apollo SystemGWG2016-03-17
783881565622397K152541Penumbra System ACE 64 and ACE 68 Reperfusion CathetersNRY2016-01-13
783881780079237K151623Penumbra System 110 Aspiration TubingNRY2015-08-06
783881201269074K151572Penumbra Smart CoilHCG2015-07-10
783881314933388K143218Penumbra Smart CoilHCG2015-03-18
783881595407658K142870Penumbra Embolectomy Aspiration System [INDIGO Aspiration System]QEW2015-05-26
783881405249910K142458Penumbra System ACENRY2015-05-22
783881077531250K142321Benchmark Intracranial Access SystemDQY2015-01-26
783881746820148K141134POD SYSTEMHCG2014-07-03
783881006681083K133317PENUMBRA SYSTEM / PENUMBRA SYSTEM MAXNRY2014-05-13
783881940282789K132931APOLLO SYSTEMGWG2014-01-17
783881349833781K122772PENUMBRA DDC CATHETERSDQY2012-11-20
783881239763593K122756PENUMBRA PUMP MAX (110VAC), PENUMBRA PUMP MAX (230VAC), PENUMBAR PUMP MAX CANISTER/TUBINGJCX2012-10-02
783881306628447K121917PENUMBRA EMBOLECTOMY ASPIRATION SYSTEMQEW2012-09-19
783881224681264K120330PENUMBRA COIL SYSTEM/PENUMBRA COIL 400HCG2012-04-02
783881275390569K113163PENUMBRA SYSTEM MAXNRY2011-11-23
783881683364233K111380NEURON MAX SYSTEMDQY2011-07-19
783881897042291K103305PENUMBRA EMBOLIZATION COIL SYSTEMHCG2011-01-26
783881132519571K100826PENUMBRA CATHERER 025DQY2010-07-13
783881750520292K100769PENUMBRA SYSTEM SEPARATOR FLEX (026,032,041,054), MODELS PSF026, PSF032, PSF041, PSF054NRY2010-05-21
783881573406534K090752PENUMBRA SYSTEM (PENNUMBRA REPERFUSION CATHETER 054), MODEL PSC054; (PENUMBRA SEPARATOR 054), MODEL PSS054NRY2009-09-21
783881923101230K083125NEURON SELECT CATHETER SIZE 070DQY2008-11-21
783881850508985K082290NEURON DELIVERY CATHETER 070DQY2008-10-31
783881761312238K072718PENUMBRA SYSTEMNRY2007-12-28
783881697500832K070970NEURON SUPPORT CATHETER SYSTEM, MODEL 5F/6FDQY2007-08-17
783881177557561K051758PENUMBRA ASPIRATION PUMP, MODEL 115VBTA2005-08-17
783881358213724

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
QEW262026-04-24
NRY242025-02-13
HCG102023-10-25
DQY92020-06-11
QJP52024-12-11
GWG42019-08-30
KRD12025-03-14
DYB12024-11-20
ISD12019-03-18
QEX12017-05-24
JCX12012-10-02
BTA12005-08-17

PMA

PMN

Applications

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