FDA.reportPublic FDA data

Penumbra Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30137585503013758550Penumbra Inc.1N2026-01-016262 Patterson Pass Rd., Suite E, Suite F Livermore CA US 94550
30156157383015615738Penumbra Inc.1N2026-01-011070 SOUTH 3800 WEST SUITE 500 Salt Lake City UT US 84104
30165913273016591327Penumbra Inc.1N2026-01-01630 Roseville Parkway Roseville CA US 95747

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2317231551910716K260599INDIGO® Aspiration System – INDIGO LinkQEW2026-04-24
2092801551910716K260599INDIGO® Aspiration System – INDIGO LinkQEW2026-04-24
2530961551910716K260599INDIGO® Aspiration System – INDIGO LinkQEW2026-04-24
2317231181454493K252612INDIGO® Aspiration System – Lightning Flash Aspiration Tubing; INDIGO® Aspiration System – Lightning Bolt Aspiration TubingQEW2025-10-16
2530961181454493K252612INDIGO® Aspiration System – Lightning Flash Aspiration Tubing; INDIGO® Aspiration System – Lightning Bolt Aspiration TubingQEW2025-10-16
2092801181454493K252612INDIGO® Aspiration System – Lightning Flash Aspiration Tubing; INDIGO® Aspiration System – Lightning Bolt Aspiration TubingQEW2025-10-16
2317231008436129K251949INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINKQEW2026-02-05
2530961008436129K251949INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINKQEW2026-02-05
2092801008436129K251949INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINKQEW2026-02-05
2317231495888409K250690Penumbra System (Thunderbolt Aspiration Tubing)NRY2026-06-10
2530961495888409K250690Penumbra System (Thunderbolt Aspiration Tubing)NRY2026-06-10
2092801495888409K250690Penumbra System (Thunderbolt Aspiration Tubing)NRY2026-06-10
2317232043486310K250079Ruby XL SystemKRD2025-03-14
2092802043486310K250079Ruby XL SystemKRD2025-03-14
2530962043486310K250079Ruby XL SystemKRD2025-03-14
2092801572824930K242520Element Vascular Access SystemDYB2024-11-20
2530961572824930K242520Element Vascular Access SystemDYB2024-11-20
2317231572824930K242520Element Vascular Access SystemDYB2024-11-20
2317231652142751K242319Indigo® Aspiration System – Aspiration Catheter 6XQEW2024-09-03
2530961652142751K242319Indigo® Aspiration System – Aspiration Catheter 6XQEW2024-09-03
2092801652142751K242319Indigo® Aspiration System – Aspiration Catheter 6XQEW2024-09-03
2317231489797662K242104Penumbra System (Reperfusion Catheter RED 72)NRY2025-02-13
2092801489797662K242104Penumbra System (Reperfusion Catheter RED 72)NRY2025-02-13
2530961489797662K242104Penumbra System (Reperfusion Catheter RED 72)NRY2025-02-13
2317231740942741K242075Indigo® Aspiration System – Lightning Bolt Aspiration TubingQEW2024-09-25
2092801740942741K242075Indigo® Aspiration System – Lightning Bolt Aspiration TubingQEW2024-09-25
2530961740942741K242075Indigo® Aspiration System – Lightning Bolt Aspiration TubingQEW2024-09-25
2317231174938289K242033Access25™ Delivery MicrocatheterQJP2024-12-11
2530961174938289K242033Access25™ Delivery MicrocatheterQJP2024-12-11
2092801174938289K242033Access25™ Delivery MicrocatheterQJP2024-12-11
2317231194484911K241399Indigo® Lightning Flash Aspiration System – Select +™ CatheterQEW2024-06-10
2530961194484911K241399Indigo® Lightning Flash Aspiration System – Select +™ CatheterQEW2024-06-10
2092801194484911K241399Indigo® Lightning Flash Aspiration System – Select +™ CatheterQEW2024-06-10
2530961294333433K240030Indigo® Aspiration System - Lightning® FlashQEW2024-02-02
2092801294333433K240030Indigo® Aspiration System - Lightning® FlashQEW2024-02-02
2317231294333433K240030Indigo® Aspiration System - Lightning® FlashQEW2024-02-02
2092801132657461K233201MIDWAY Delivery Catheter (MIDWAY 43 Delivery Catheter; MIDWAY 62 Delivery Catheter)QJP2024-03-27
2317231132657461K233201MIDWAY Delivery Catheter (MIDWAY 43 Delivery Catheter; MIDWAY 62 Delivery Catheter)QJP2024-03-27
2530961132657461K233201MIDWAY Delivery Catheter (MIDWAY 43 Delivery Catheter; MIDWAY 62 Delivery Catheter)QJP2024-03-27
2530961383648886K230284Penumbra LP Coil SystemHCG2023-10-25
2092801383648886K230284Penumbra LP Coil SystemHCG2023-10-25
2317231383648886K230284Penumbra LP Coil SystemHCG2023-10-25
2317231056585235K223186Indigo® Aspiration System – Lightning Bolt Aspiration TubingQEW2023-02-13
2530961056585235K223186Indigo® Aspiration System – Lightning Bolt Aspiration TubingQEW2023-02-13
2092801056585235K223186Indigo® Aspiration System – Lightning Bolt Aspiration TubingQEW2023-02-13
2317231758888018K222808Penumbra System (Reperfusion Catheter RED 43)NRY2022-12-20
2092801758888018K222808Penumbra System (Reperfusion Catheter RED 43)NRY2022-12-20
2530961758888018K222808Penumbra System (Reperfusion Catheter RED 43)NRY2022-12-20
2317231339396787K222358Indigo Aspiration System - Lightning FlashQEW2022-12-20
2092801339396787K222358Indigo Aspiration System - Lightning FlashQEW2022-12-20
2530961339396787K222358Indigo Aspiration System - Lightning FlashQEW2022-12-20
2092801629638004K221822BENCHMARK BMX81 Access SystemQJP2022-11-04
2530961629638004K221822BENCHMARK BMX81 Access SystemQJP2022-11-04
2317231629638004K221822BENCHMARK BMX81 Access SystemQJP2022-11-04
2317231914040107K220683INDIGO Aspiration System (CAT RX Aspiration Catheter and Separator 4)QEW2022-10-04
2092801914040107K220683INDIGO Aspiration System (CAT RX Aspiration Catheter and Separator 4)QEW2022-10-04
2530961914040107K220683INDIGO Aspiration System (CAT RX Aspiration Catheter and Separator 4)QEW2022-10-04
2317231506977357K213390Benchmark BMX96 Access SystemQJP2022-08-18
2092801506977357K213390Benchmark BMX96 Access SystemQJP2022-08-18
2530961506977357K213390Benchmark BMX96 Access SystemQJP2022-08-18
2317232044405334K212838Benchmark Intracranial Access SystemQJP2022-05-27
2530962044405334K212838Benchmark Intracranial Access SystemQJP2022-05-27
2092802044405334K212838Benchmark Intracranial Access SystemQJP2022-05-27
2530961209199922K211654Penumbra System (Reperfusion Catheter RED 72)NRY2021-08-16
2092801209199922K211654Penumbra System (Reperfusion Catheter RED 72)NRY2021-08-16
2317231209199922K211654Penumbra System (Reperfusion Catheter RED 72)NRY2021-08-16
2092801644891940K211411Penumbra System (RED 68 Reperfusion Catheter)NRY2021-07-01
2530961644891940K211411Penumbra System (RED 68 Reperfusion Catheter)NRY2021-07-01
2317231644891940K211411Penumbra System (RED 68 Reperfusion Catheter)NRY2021-07-01
2317231970468153K210323Indigo Aspiration System - Lightning Aspiration TubingQEW2021-02-26
2092801970468153K210323Indigo Aspiration System - Lightning Aspiration TubingQEW2021-02-26
2530961970468153K210323Indigo Aspiration System - Lightning Aspiration TubingQEW2021-02-26
2317231930904780K210083Indigo System Aspiration Catheter 7, Indigo Aspiration System Separator 7, Lightning 7QEW2021-02-09
2092801930904780K210083Indigo System Aspiration Catheter 7, Indigo Aspiration System Separator 7, Lightning 7QEW2021-02-09
2530961930904780K210083Indigo System Aspiration Catheter 7, Indigo Aspiration System Separator 7, Lightning 7QEW2021-02-09
2317231603585411K203440Penumbra System (Reperfusion Catheter RED 62)NRY2021-05-20
2530961603585411K203440Penumbra System (Reperfusion Catheter RED 62)NRY2021-05-20
2092801603585411K203440Penumbra System (Reperfusion Catheter RED 62)NRY2021-05-20
2317232073701803K202821Indigo Aspiration System - Aspiration Catheter 12 and Separator 12QEW2020-11-18
2530962073701803K202821Indigo Aspiration System - Aspiration Catheter 12 and Separator 12QEW2020-11-18
2092802073701803K202821Indigo Aspiration System - Aspiration Catheter 12 and Separator 12QEW2020-11-18
2317231386440874K202251Penumbra System (Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology; Penumbra JET 7MAX)NRY2020-08-31
2530961386440874K202251Penumbra System (Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology; Penumbra JET 7MAX)NRY2020-08-31
2092801386440874K202251Penumbra System (Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology; Penumbra JET 7MAX)NRY2020-08-31
2317231837281032K201271Benchmark BMX96 Access SystemDQY2020-06-11
2530961837281032K201271Benchmark BMX96 Access SystemDQY2020-06-11
2092801837281032K201271Benchmark BMX96 Access SystemDQY2020-06-11
2530961230002469K200771Indigo Aspiration System Lightning Aspiration TubingQEW2020-04-22
2092801230002469K200771Indigo Aspiration System Lightning Aspiration TubingQEW2020-04-22
2317231230002469K200771Indigo Aspiration System Lightning Aspiration TubingQEW2020-04-22
2317231196004931K193595Indigo Aspiration System - Aspiration Catheter 7 and Separator 7QEW2020-08-19
2092801196004931K193595Indigo Aspiration System - Aspiration Catheter 7 and Separator 7QEW2020-08-19
2530961196004931K193595Indigo Aspiration System - Aspiration Catheter 7 and Separator 7QEW2020-08-19
2092801955955193K193244Indigo Aspiration System – Lightning Aspiration TubingQEW2020-03-13
2317231955955193K193244Indigo Aspiration System – Lightning Aspiration TubingQEW2020-03-13
2530961955955193K193244Indigo Aspiration System – Lightning Aspiration TubingQEW2020-03-13
2092801831384577K192981Indigo System Aspiration Catheter 12, Indigo Aspiration System Separator 12QEW2020-05-28
2530961831384577K192981Indigo System Aspiration Catheter 12, Indigo Aspiration System Separator 12QEW2020-05-28
2317231831384577K192981Indigo System Aspiration Catheter 12, Indigo Aspiration System Separator 12QEW2020-05-28
2092801020083565K192955Penumbra LP Coil SystemHCG2019-11-20
2317231020083565K192955Penumbra LP Coil SystemHCG2019-11-20
2530961020083565K192955Penumbra LP Coil SystemHCG2019-11-20
2092801359823883K192833Indigo Aspiration SystemQEW2019-12-20
2317231359823883K192833Indigo Aspiration SystemQEW2019-12-20
2530961359823883K192833Indigo Aspiration SystemQEW2019-12-20
2092801550865111K191946Penumbra System Penumbra JET 7XNRY2020-02-27
2317231550865111K191946Penumbra System Penumbra JET 7XNRY2020-02-27
2530961550865111K191946Penumbra System Penumbra JET 7XNRY2020-02-27
2317232053866862K190719Artemis Eye SystemGWG2019-08-30
2092802053866862K190719Artemis Eye SystemGWG2019-08-30
2530962053866862K190719Artemis Eye SystemGWG2019-08-30
2092801301233463K190464Penumbra System 3D Revascularization DeviceNRY2019-04-26
2317231301233463K190464Penumbra System 3D Revascularization DeviceNRY2019-04-26
2530961301233463K190464Penumbra System 3D Revascularization DeviceNRY2019-04-26
2092801731483088K190010Penumbra System Reperfusion Catheter JET 7NRY2019-06-16
2317231731483088K190010Penumbra System Reperfusion Catheter JET 7NRY2019-06-16
2530961731483088K190010Penumbra System Reperfusion Catheter JET 7NRY2019-06-16
2317231004659519K183296REAL Immersive SystemISD2019-03-18
2092801004659519K183296REAL Immersive SystemISD2019-03-18
2530961004659519K183296REAL Immersive SystemISD2019-03-18

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
QEW782026-04-24
NRY752026-06-10
HCG302023-10-25
DQY282020-06-11
QJP152024-12-11
GWG122019-08-30
KRD32025-03-14
DYB32024-11-20
ISD32019-03-18
QEX32017-05-24
JCX32012-10-02
BTA32005-08-17
LIT12010-01-15