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Penumbra, Inc.

87 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
Penumbra System (Thunderbolt Aspiration Tubing) (K250690)Penumbra, Inc.2026-06-10
INDIGO® Aspiration System – INDIGO Link (K260599)Penumbra, Inc.2026-04-24
INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK (K251949)Penumbra, Inc.2026-02-05
INDIGO® Aspiration System – Lightning Flash Aspiration Tubing; INDIGO® Aspiration System – Lightning Bolt Aspiration Tubing (K252612)Penumbra, Inc.2025-10-16
Ruby XL System (K250079)Penumbra, Inc.2025-03-14
Penumbra System (Reperfusion Catheter RED 72) (K242104)Penumbra, Inc.2025-02-13
Access25™ Delivery Microcatheter (K242033)Penumbra, Inc.2024-12-11
Element Vascular Access System (K242520)Penumbra, Inc.2024-11-20
Indigo® Aspiration System – Lightning Bolt Aspiration Tubing (K242075)Penumbra, Inc.2024-09-25
Indigo® Aspiration System – Aspiration Catheter 6X (K242319)Penumbra, Inc.2024-09-03
Indigo® Lightning Flash Aspiration System – Select +™ Catheter (K241399)Penumbra, Inc.2024-06-10
MIDWAY Delivery Catheter (MIDWAY 43 Delivery Catheter; MIDWAY 62 Delivery Catheter) (K233201)Penumbra, Inc.2024-03-27
Indigo® Aspiration System - Lightning® Flash (K240030)Penumbra, Inc.2024-02-02
Penumbra LP Coil System (K230284)Penumbra, Inc.2023-10-25
Indigo® Aspiration System – Lightning Bolt Aspiration Tubing (K223186)Penumbra, Inc.2023-02-13
Indigo Aspiration System - Lightning Flash (K222358)Penumbra, Inc.2022-12-20
Penumbra System (Reperfusion Catheter RED 43) (K222808)Penumbra, Inc.2022-12-20
BENCHMARK BMX81 Access System (K221822)Penumbra, Inc.2022-11-04
INDIGO Aspiration System (CAT RX Aspiration Catheter and Separator 4) (K220683)Penumbra, Inc.2022-10-04
Benchmark BMX96 Access System (K213390)Penumbra, Inc.2022-08-18
Benchmark Intracranial Access System (K212838)Penumbra, Inc.2022-05-27
Penumbra System (Reperfusion Catheter RED 72) (K211654)Penumbra, Inc.2021-08-16
Penumbra System (RED 68 Reperfusion Catheter) (K211411)Penumbra, Inc.2021-07-01
Penumbra System (Reperfusion Catheter RED 62) (K203440)Penumbra, Inc.2021-05-20
Indigo Aspiration System - Lightning Aspiration Tubing (K210323)Penumbra, Inc.2021-02-26
Indigo System Aspiration Catheter 7, Indigo Aspiration System Separator 7, Lightning 7 (K210083)Penumbra, Inc.2021-02-09
Indigo Aspiration System - Aspiration Catheter 12 and Separator 12 (K202821)Penumbra, Inc.2020-11-18
Penumbra System (Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology; Penumbra JET 7MAX) (K202251)Penumbra, Inc.2020-08-31
Indigo Aspiration System - Aspiration Catheter 7 and Separator 7 (K193595)Penumbra, Inc.2020-08-19
Benchmark BMX96 Access System (K201271)Penumbra, Inc.2020-06-11
Indigo System Aspiration Catheter 12, Indigo Aspiration System Separator 12 (K192981)Penumbra, Inc.2020-05-28
Indigo Aspiration System Lightning Aspiration Tubing (K200771)Penumbra, Inc.2020-04-22
Indigo Aspiration System – Lightning Aspiration Tubing (K193244)Penumbra, Inc.2020-03-13
Penumbra System Penumbra JET 7X (K191946)Penumbra, Inc.2020-02-27
Indigo Aspiration System (K192833)Penumbra, Inc.2019-12-20
Penumbra LP Coil System (K192955)Penumbra, Inc.2019-11-20
Artemis Eye System (K190719)Penumbra, Inc.2019-08-30
Penumbra System Reperfusion Catheter JET 7 (K190010)Penumbra, Inc.2019-06-16
Penumbra System 3D Revascularization Device (K190464)Penumbra, Inc.2019-04-26
REAL Immersive System (K183296)Penumbra, Inc.2019-03-18
Penumbra System (Modified 110 Aspiration Tubing) (K182522)Penumbra, Inc.2018-10-12
Penumbra System Reperfusion Catheter JET 7 (K173761)Penumbra, Inc.2018-08-17
Penumbra System (K180008)Penumbra, Inc.2018-06-20
Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump and Canister (K180412)Penumbra, Inc.2018-05-15
Indigo Aspiration System - Modified 110 Aspiration Tubing (K180939)Penumbra, Inc.2018-05-03
Penumbra Coil 400, Ruby Coil System, POD System (K173614)Penumbra, Inc.2018-04-17
Indigo Aspiration System - Penumbra Engine Pump, Indigo Aspiration System - Penumbra Engine Pump Canister (K180105)Penumbra, Inc.2018-03-08
Artemis Neuro Evacuation Device (K171332)Penumbra, Inc.2017-08-14
POD Packing Coil (K170852)Penumbra, Inc.2017-07-19
INDIGO Aspiration System (K163618)Penumbra, Inc.2017-05-24
Penumbra 3D Revascularization Device (K162901)Penumbra, Inc.2017-04-20
Penumbra Aspiration System (K161506)Penumbra, Inc.2016-09-26
Penumbra System ACE 68 Reperfusion Catheter (K161640)Penumbra, Inc.2016-07-12
INDIGO Aspiration System (K161523)Penumbra, Inc.2016-07-01
Penumbra System ACE 68 Reperfusion Catheter (K161064)Penumbra, Inc.2016-06-12
Penumbra System, Penumbra Pump MAX (K160449)Penumbra, Inc.2016-05-25
Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System) (K160533)Penumbra, Inc.2016-05-24
Penumbra Smart Coil (K160832)Penumbra, Inc.2016-04-20
Apollo System (K152699)Penumbra, Inc.2016-03-17
Penumbra System ACE 64 and ACE 68 Reperfusion Catheters (K152541)Penumbra, Inc.2016-01-13
Lantern Delivery Microcatheter (K152840)Penumbra, Inc.2015-12-02
Penumbra System 110 Aspiration Tubing (K151623)Penumbra, Inc.2015-08-06
Penumbra Smart Coil (K151572)Penumbra, Inc.2015-07-10
Penumbra Embolectomy Aspiration System [INDIGO Aspiration System] (K142870)Penumbra, Inc.2015-05-26
Penumbra System ACE (K142458)Penumbra, Inc.2015-05-22
Penumbra Smart Coil (K143218)Penumbra, Inc.2015-03-18
Benchmark Intracranial Access System (K142321)Penumbra, Inc.2015-01-26
POD SYSTEM (K141134)Penumbra, Inc.2014-07-03
PENUMBRA SYSTEM / PENUMBRA SYSTEM MAX (K133317)Penumbra, Inc.2014-05-13
APOLLO SYSTEM (K132931)Penumbra, Inc.2014-01-17
PENUMBRA DDC CATHETERS (K122772)Penumbra, Inc.2012-11-20
PENUMBRA PUMP MAX (110VAC), PENUMBRA PUMP MAX (230VAC), PENUMBAR PUMP MAX CANISTER/TUBING (K122756)Penumbra, Inc.2012-10-02
PENUMBRA EMBOLECTOMY ASPIRATION SYSTEM (K121917)Penumbra, Inc.2012-09-19
PENUMBRA COIL SYSTEM/PENUMBRA COIL 400 (K120330)Penumbra, Inc.2012-04-02
PENUMBRA SYSTEM MAX (K113163)Penumbra, Inc.2011-11-23
NEURON MAX SYSTEM (K111380)Penumbra, Inc.2011-07-19
PENUMBRA EMBOLIZATION COIL SYSTEM (K103305)Penumbra, Inc.2011-01-26
PENUMBRA CATHERER 025 (K100826)Penumbra, Inc.2010-07-13
PENUMBRA SYSTEM SEPARATOR FLEX (026,032,041,054), MODELS PSF026, PSF032, PSF041, PSF054 (K100769)Penumbra, Inc.2010-05-21
PICA CATHETER (K093970)Penumbra, Inc.2010-01-15
PENUMBRA SYSTEM (PENNUMBRA REPERFUSION CATHETER 054), MODEL PSC054; (PENUMBRA SEPARATOR 054), MODEL PSS054 (K090752)Penumbra, Inc.2009-09-21
NEURON SELECT CATHETER SIZE 070 (K083125)Penumbra, Inc.2008-11-21
NEURON DELIVERY CATHETER 070 (K082290)Penumbra, Inc.2008-10-31
PENUMBRA SYSTEM (K072718)Penumbra, Inc.2007-12-28
NEURON SUPPORT CATHETER SYSTEM, MODEL 5F/6F (K070970)Penumbra, Inc.2007-08-17
PENUMBRA BALLOON GUIDE CATHETER, MODEL 7.5F (K053491)Penumbra, Inc.2006-04-27
PENUMBRA ASPIRATION PUMP, MODEL 115V (K051758)Penumbra, Inc.2005-08-17

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Every clearance here is in the API, with alerts when new ones post.