PENUMBRA, INC.

Matched from indexed company URL: Penumbra, Inc

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3005168196	3005168196	PENUMBRA, INC.	1	N	2026-01-01	One Penumbra Place Alameda CA US 94502
3013758550	3013758550	Penumbra Inc.	1	N	2026-01-01	6262 Patterson Pass Rd., Suite E, Suite F Livermore CA US 94550
3015615738	3015615738	Penumbra Inc.	1	N	2026-01-01	1070 SOUTH 3800 WEST SUITE 500 Salt Lake City UT US 84104
3016591327	3016591327	Penumbra Inc.	1	N	2026-01-01	630 Roseville Parkway Roseville CA US 95747

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
78388	1551910716	K260599	INDIGO® Aspiration System – INDIGO Link	QEW	2026-04-24
209280	1551910716	K260599	INDIGO® Aspiration System – INDIGO Link	QEW	2026-04-24
231723	1551910716	K260599	INDIGO® Aspiration System – INDIGO Link	QEW	2026-04-24
253096	1551910716	K260599	INDIGO® Aspiration System – INDIGO Link	QEW	2026-04-24
78388	1181454493	K252612	INDIGO® Aspiration System – Lightning Flash Aspiration Tubing; INDIGO® Aspiration System – Lightning Bolt Aspiration Tubing	QEW	2025-10-16
209280	1181454493	K252612	INDIGO® Aspiration System – Lightning Flash Aspiration Tubing; INDIGO® Aspiration System – Lightning Bolt Aspiration Tubing	QEW	2025-10-16
231723	1181454493	K252612	INDIGO® Aspiration System – Lightning Flash Aspiration Tubing; INDIGO® Aspiration System – Lightning Bolt Aspiration Tubing	QEW	2025-10-16
253096	1181454493	K252612	INDIGO® Aspiration System – Lightning Flash Aspiration Tubing; INDIGO® Aspiration System – Lightning Bolt Aspiration Tubing	QEW	2025-10-16
78388	1008436129	K251949	INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK	QEW	2026-02-05
209280	1008436129	K251949	INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK	QEW	2026-02-05
231723	1008436129	K251949	INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK	QEW	2026-02-05
253096	1008436129	K251949	INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK	QEW	2026-02-05
78388	1495888409	K250690	Penumbra System (Thunderbolt Aspiration Tubing)	NRY	2026-06-10
209280	1495888409	K250690	Penumbra System (Thunderbolt Aspiration Tubing)	NRY	2026-06-10
231723	1495888409	K250690	Penumbra System (Thunderbolt Aspiration Tubing)	NRY	2026-06-10
253096	1495888409	K250690	Penumbra System (Thunderbolt Aspiration Tubing)	NRY	2026-06-10
78388	2043486310	K250079	Ruby XL System	KRD	2025-03-14
209280	2043486310	K250079	Ruby XL System	KRD	2025-03-14
231723	2043486310	K250079	Ruby XL System	KRD	2025-03-14
253096	2043486310	K250079	Ruby XL System	KRD	2025-03-14
78388	1572824930	K242520	Element Vascular Access System	DYB	2024-11-20
209280	1572824930	K242520	Element Vascular Access System	DYB	2024-11-20
231723	1572824930	K242520	Element Vascular Access System	DYB	2024-11-20
253096	1572824930	K242520	Element Vascular Access System	DYB	2024-11-20
78388	1652142751	K242319	Indigo® Aspiration System – Aspiration Catheter 6X	QEW	2024-09-03
209280	1652142751	K242319	Indigo® Aspiration System – Aspiration Catheter 6X	QEW	2024-09-03
231723	1652142751	K242319	Indigo® Aspiration System – Aspiration Catheter 6X	QEW	2024-09-03
253096	1652142751	K242319	Indigo® Aspiration System – Aspiration Catheter 6X	QEW	2024-09-03
78388	1489797662	K242104	Penumbra System (Reperfusion Catheter RED 72)	NRY	2025-02-13
209280	1489797662	K242104	Penumbra System (Reperfusion Catheter RED 72)	NRY	2025-02-13
231723	1489797662	K242104	Penumbra System (Reperfusion Catheter RED 72)	NRY	2025-02-13
253096	1489797662	K242104	Penumbra System (Reperfusion Catheter RED 72)	NRY	2025-02-13
78388	1740942741	K242075	Indigo® Aspiration System – Lightning Bolt Aspiration Tubing	QEW	2024-09-25
209280	1740942741	K242075	Indigo® Aspiration System – Lightning Bolt Aspiration Tubing	QEW	2024-09-25
231723	1740942741	K242075	Indigo® Aspiration System – Lightning Bolt Aspiration Tubing	QEW	2024-09-25
253096	1740942741	K242075	Indigo® Aspiration System – Lightning Bolt Aspiration Tubing	QEW	2024-09-25
78388	1174938289	K242033	Access25™ Delivery Microcatheter	QJP	2024-12-11
209280	1174938289	K242033	Access25™ Delivery Microcatheter	QJP	2024-12-11
231723	1174938289	K242033	Access25™ Delivery Microcatheter	QJP	2024-12-11
253096	1174938289	K242033	Access25™ Delivery Microcatheter	QJP	2024-12-11
78388	1194484911	K241399	Indigo® Lightning Flash Aspiration System – Select +™ Catheter	QEW	2024-06-10
209280	1194484911	K241399	Indigo® Lightning Flash Aspiration System – Select +™ Catheter	QEW	2024-06-10
231723	1194484911	K241399	Indigo® Lightning Flash Aspiration System – Select +™ Catheter	QEW	2024-06-10
253096	1194484911	K241399	Indigo® Lightning Flash Aspiration System – Select +™ Catheter	QEW	2024-06-10
78388	1294333433	K240030	Indigo® Aspiration System - Lightning® Flash	QEW	2024-02-02
209280	1294333433	K240030	Indigo® Aspiration System - Lightning® Flash	QEW	2024-02-02
231723	1294333433	K240030	Indigo® Aspiration System - Lightning® Flash	QEW	2024-02-02
253096	1294333433	K240030	Indigo® Aspiration System - Lightning® Flash	QEW	2024-02-02
78388	1132657461	K233201	MIDWAY Delivery Catheter (MIDWAY 43 Delivery Catheter; MIDWAY 62 Delivery Catheter)	QJP	2024-03-27
209280	1132657461	K233201	MIDWAY Delivery Catheter (MIDWAY 43 Delivery Catheter; MIDWAY 62 Delivery Catheter)	QJP	2024-03-27
231723	1132657461	K233201	MIDWAY Delivery Catheter (MIDWAY 43 Delivery Catheter; MIDWAY 62 Delivery Catheter)	QJP	2024-03-27
253096	1132657461	K233201	MIDWAY Delivery Catheter (MIDWAY 43 Delivery Catheter; MIDWAY 62 Delivery Catheter)	QJP	2024-03-27
78388	1383648886	K230284	Penumbra LP Coil System	HCG	2023-10-25
209280	1383648886	K230284	Penumbra LP Coil System	HCG	2023-10-25
231723	1383648886	K230284	Penumbra LP Coil System	HCG	2023-10-25
253096	1383648886	K230284	Penumbra LP Coil System	HCG	2023-10-25
78388	1056585235	K223186	Indigo® Aspiration System – Lightning Bolt Aspiration Tubing	QEW	2023-02-13
209280	1056585235	K223186	Indigo® Aspiration System – Lightning Bolt Aspiration Tubing	QEW	2023-02-13
231723	1056585235	K223186	Indigo® Aspiration System – Lightning Bolt Aspiration Tubing	QEW	2023-02-13
253096	1056585235	K223186	Indigo® Aspiration System – Lightning Bolt Aspiration Tubing	QEW	2023-02-13
78388	1758888018	K222808	Penumbra System (Reperfusion Catheter RED 43)	NRY	2022-12-20
209280	1758888018	K222808	Penumbra System (Reperfusion Catheter RED 43)	NRY	2022-12-20
231723	1758888018	K222808	Penumbra System (Reperfusion Catheter RED 43)	NRY	2022-12-20
253096	1758888018	K222808	Penumbra System (Reperfusion Catheter RED 43)	NRY	2022-12-20
78388	1339396787	K222358	Indigo Aspiration System - Lightning Flash	QEW	2022-12-20
209280	1339396787	K222358	Indigo Aspiration System - Lightning Flash	QEW	2022-12-20
231723	1339396787	K222358	Indigo Aspiration System - Lightning Flash	QEW	2022-12-20
253096	1339396787	K222358	Indigo Aspiration System - Lightning Flash	QEW	2022-12-20
78388	1629638004	K221822	BENCHMARK BMX81 Access System	QJP	2022-11-04
209280	1629638004	K221822	BENCHMARK BMX81 Access System	QJP	2022-11-04
231723	1629638004	K221822	BENCHMARK BMX81 Access System	QJP	2022-11-04
253096	1629638004	K221822	BENCHMARK BMX81 Access System	QJP	2022-11-04
78388	1914040107	K220683	INDIGO Aspiration System (CAT RX Aspiration Catheter and Separator 4)	QEW	2022-10-04
209280	1914040107	K220683	INDIGO Aspiration System (CAT RX Aspiration Catheter and Separator 4)	QEW	2022-10-04
231723	1914040107	K220683	INDIGO Aspiration System (CAT RX Aspiration Catheter and Separator 4)	QEW	2022-10-04
253096	1914040107	K220683	INDIGO Aspiration System (CAT RX Aspiration Catheter and Separator 4)	QEW	2022-10-04
78388	1506977357	K213390	Benchmark BMX96 Access System	QJP	2022-08-18
209280	1506977357	K213390	Benchmark BMX96 Access System	QJP	2022-08-18
231723	1506977357	K213390	Benchmark BMX96 Access System	QJP	2022-08-18
253096	1506977357	K213390	Benchmark BMX96 Access System	QJP	2022-08-18
78388	2044405334	K212838	Benchmark Intracranial Access System	QJP	2022-05-27
209280	2044405334	K212838	Benchmark Intracranial Access System	QJP	2022-05-27
231723	2044405334	K212838	Benchmark Intracranial Access System	QJP	2022-05-27
253096	2044405334	K212838	Benchmark Intracranial Access System	QJP	2022-05-27
78388	1209199922	K211654	Penumbra System (Reperfusion Catheter RED 72)	NRY	2021-08-16
209280	1209199922	K211654	Penumbra System (Reperfusion Catheter RED 72)	NRY	2021-08-16
231723	1209199922	K211654	Penumbra System (Reperfusion Catheter RED 72)	NRY	2021-08-16
253096	1209199922	K211654	Penumbra System (Reperfusion Catheter RED 72)	NRY	2021-08-16
78388	1644891940	K211411	Penumbra System (RED 68 Reperfusion Catheter)	NRY	2021-07-01
209280	1644891940	K211411	Penumbra System (RED 68 Reperfusion Catheter)	NRY	2021-07-01
231723	1644891940	K211411	Penumbra System (RED 68 Reperfusion Catheter)	NRY	2021-07-01
253096	1644891940	K211411	Penumbra System (RED 68 Reperfusion Catheter)	NRY	2021-07-01
78388	1970468153	K210323	Indigo Aspiration System - Lightning Aspiration Tubing	QEW	2021-02-26
209280	1970468153	K210323	Indigo Aspiration System - Lightning Aspiration Tubing	QEW	2021-02-26
231723	1970468153	K210323	Indigo Aspiration System - Lightning Aspiration Tubing	QEW	2021-02-26
253096	1970468153	K210323	Indigo Aspiration System - Lightning Aspiration Tubing	QEW	2021-02-26
78388	1930904780	K210083	Indigo System Aspiration Catheter 7, Indigo Aspiration System Separator 7, Lightning 7	QEW	2021-02-09
209280	1930904780	K210083	Indigo System Aspiration Catheter 7, Indigo Aspiration System Separator 7, Lightning 7	QEW	2021-02-09
231723	1930904780	K210083	Indigo System Aspiration Catheter 7, Indigo Aspiration System Separator 7, Lightning 7	QEW	2021-02-09
253096	1930904780	K210083	Indigo System Aspiration Catheter 7, Indigo Aspiration System Separator 7, Lightning 7	QEW	2021-02-09
78388	1603585411	K203440	Penumbra System (Reperfusion Catheter RED 62)	NRY	2021-05-20
209280	1603585411	K203440	Penumbra System (Reperfusion Catheter RED 62)	NRY	2021-05-20
231723	1603585411	K203440	Penumbra System (Reperfusion Catheter RED 62)	NRY	2021-05-20
253096	1603585411	K203440	Penumbra System (Reperfusion Catheter RED 62)	NRY	2021-05-20
78388	2073701803	K202821	Indigo Aspiration System - Aspiration Catheter 12 and Separator 12	QEW	2020-11-18
209280	2073701803	K202821	Indigo Aspiration System - Aspiration Catheter 12 and Separator 12	QEW	2020-11-18
231723	2073701803	K202821	Indigo Aspiration System - Aspiration Catheter 12 and Separator 12	QEW	2020-11-18
253096	2073701803	K202821	Indigo Aspiration System - Aspiration Catheter 12 and Separator 12	QEW	2020-11-18
78388	1386440874	K202251	Penumbra System (Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology; Penumbra JET 7MAX)	NRY	2020-08-31
209280	1386440874	K202251	Penumbra System (Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology; Penumbra JET 7MAX)	NRY	2020-08-31
231723	1386440874	K202251	Penumbra System (Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology; Penumbra JET 7MAX)	NRY	2020-08-31
253096	1386440874	K202251	Penumbra System (Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology; Penumbra JET 7MAX)	NRY	2020-08-31
78388	1837281032	K201271	Benchmark BMX96 Access System	DQY	2020-06-11
209280	1837281032	K201271	Benchmark BMX96 Access System	DQY	2020-06-11
231723	1837281032	K201271	Benchmark BMX96 Access System	DQY	2020-06-11
253096	1837281032	K201271	Benchmark BMX96 Access System	DQY	2020-06-11
78388	1230002469	K200771	Indigo Aspiration System Lightning Aspiration Tubing	QEW	2020-04-22
209280	1230002469	K200771	Indigo Aspiration System Lightning Aspiration Tubing	QEW	2020-04-22
231723	1230002469	K200771	Indigo Aspiration System Lightning Aspiration Tubing	QEW	2020-04-22
253096	1230002469	K200771	Indigo Aspiration System Lightning Aspiration Tubing	QEW	2020-04-22

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
QEW	104	2026-04-24
NRY	100	2026-06-10
HCG	40	2023-10-25
DQY	37	2020-06-11
QJP	20	2024-12-11
GWG	16	2019-08-30
KRD	4	2025-03-14
DYB	4	2024-11-20
ISD	4	2019-03-18
QEX	4	2017-05-24
JCX	4	2012-10-02
BTA	4	2005-08-17
LIT	1	2010-01-15

PMN#

INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK
2026-02-05
Penumbra, Inc.
INDIGO® Aspiration System ? Lightning Flash Aspiration Tubing; INDIGO® Aspiration System ? Lightning Bolt Aspiration Tubing
2025-10-16
Penumbra, Inc.
Ruby XL System
2025-03-14
Penumbra, Inc.
Penumbra System (Reperfusion Catheter RED 72)
2025-02-13
Penumbra, Inc.
Access25? Delivery Microcatheter
2024-12-11
Penumbra, Inc.
Element Vascular Access System
2024-11-20
Penumbra, Inc.
Indigo® Aspiration System ? Lightning Bolt Aspiration Tubing
2024-09-25
Penumbra, Inc.
Indigo® Aspiration System ? Aspiration Catheter 6X
2024-09-03
Penumbra, Inc.
Indigo® Lightning Flash Aspiration System ? Select +? Catheter
2024-06-10
Penumbra, Inc.
MIDWAY Delivery Catheter (MIDWAY 43 Delivery Catheter; MIDWAY 62 Delivery Catheter)
2024-03-27
Penumbra, Inc.
Indigo® Aspiration System - Lightning® Flash
2024-02-02
Penumbra, Inc.
Penumbra LP Coil System
2023-10-25
Penumbra, Inc.
Indigo® Aspiration System ? Lightning Bolt Aspiration Tubing
2023-02-13
Penumbra, Inc.
Penumbra System (Reperfusion Catheter RED 43)
2022-12-20
Penumbra, Inc.
Indigo Aspiration System - Lightning Flash
2022-12-20
Penumbra, Inc.
BENCHMARK BMX81 Access System
2022-11-04
Penumbra, Inc
INDIGO Aspiration System (CAT RX Aspiration Catheter and Separator 4)
2022-10-04
Penumbra, Inc.
Benchmark BMX96 Access System
2022-08-18
Penumbra, Inc.
Benchmark Intracranial Access System
2022-05-27
Penumbra, Inc.
Penumbra System (Reperfusion Catheter RED 72)
2021-08-16
Penumbra, Inc.
Penumbra System (RED 68 Reperfusion Catheter)
2021-07-01
Penumbra, Inc.
Penumbra System (Reperfusion Catheter RED 62)
2021-05-20
Penumbra, Inc.
Indigo Aspiration System - Lightning Aspiration Tubing
2021-02-26
Penumbra, Inc.
Indigo System Aspiration Catheter 7, Indigo Aspiration System Separator 7, Lightning 7
2021-02-09
Penumbra, Inc.
Indigo Aspiration System - Aspiration Catheter 12 and Separator 12
2020-11-18
Penumbra, Inc.
Penumbra System (Penumbra JET 7 Reperfusion Catheter With Xtra Flex Technology; Penumbra JET 7MAX)
2020-08-31
Penumbra, Inc.
Indigo Aspiration System - Aspiration Catheter 7 And Separator 7
2020-08-19
Penumbra, Inc.
Benchmark BMX96 Access System
2020-06-11
Penumbra, Inc.
Indigo System Aspiration Catheter 12, Indigo Aspiration System Separator 12
2020-05-28
Penumbra, Inc
Indigo Aspiration System Lightning Aspiration Tubing
2020-04-22
Penumbra, Inc.
Indigo Aspiration System – Lightning Aspiration Tubing
2020-03-13
Penumbra, Inc.
Penumbra System Penumbra JET 7X
2020-02-27
Penumbra, Inc.
Indigo Aspiration System
2019-12-20
Penumbra, Inc.
Penumbra LP Coil System
2019-11-20
Penumbra, Inc.
Artemis Eye System
2019-08-30
Penumbra, Inc.
Penumbra System Reperfusion Catheter JET 7
2019-06-16
Penumbra, Inc.
Penumbra System 3D Revascularization Device
2019-04-26
Penumbra, Inc.
REAL Immersive System
2019-03-18
Penumbra, Inc.
Penumbra System (Modified 110 Aspiration Tubing)
2018-10-12
Penumbra, Inc.
Penumbra System Reperfusion Catheter JET 7
2018-08-17
Penumbra, Inc.

85 records. Showing 1-40. Next

GUDID#

Smart Coil - 400SMTXSFT4H12
PENUMBRA, INC.
2016-07-30
Smart Coil - 400SMTXSFT3H08
PENUMBRA, INC.
2016-07-30
Smart Coil - 400SMTXSFT3H06
PENUMBRA, INC.
2016-07-30
Smart Coil - SmtCoil-XSft, 2x6
PENUMBRA, INC.
2016-07-30
Smart Coil - SmtCoil-XSft, 2.5x8
PENUMBRA, INC.
2016-07-30
Smart Coil - SmtCoil-XSft, 2x8
PENUMBRA, INC.
2016-07-30
Smart Coil - SmtCoil-XSft, 1x4
PENUMBRA, INC.
2016-07-30
Smart Coil - SmtCoil-XSft, 4x10
PENUMBRA, INC.
2016-07-30
Smart Coil - SmtCoil-XSft, 4x8
PENUMBRA, INC.
2016-07-30
Smart Coil - SmtCoil-XSft, 4x6
PENUMBRA, INC.
2016-07-30
Smart Coil - SmtCoil-XSft, 3x8
PENUMBRA, INC.
2016-07-30
Smart Coil - SmtCoil-XSft, 3x6
PENUMBRA, INC.
2016-07-30
Smart Coil - SmtCoil-XSft, 3x4
PENUMBRA, INC.
2016-07-30
Smart Coil - SmtCoil-XSft, 2.5x6
PENUMBRA, INC.
2016-07-30
Smart Coil - SmtCoil-XSft, 2.5x4
PENUMBRA, INC.
2016-07-30
Smart Coil - SmtCoil-XSft, 2.5x3
PENUMBRA, INC.
2016-07-30
Smart Coil - SmtCoil-XSft, 2x5
PENUMBRA, INC.
2016-07-30
Smart Coil - SmtCoil-XSft, 2x4
PENUMBRA, INC.
2016-07-30
Smart Coil - SmtCoil-XSft, 2x3
PENUMBRA, INC.
2016-07-30
Smart Coil - SmtCoil-XSft, 2x2
PENUMBRA, INC.
2016-07-30
Smart Coil - SmtCoil-XSft, 1.5x4
PENUMBRA, INC.
2016-07-30
Smart Coil - SmtCoil-XSft, 1.5x3
PENUMBRA, INC.
2016-07-30
Smart Coil - SmtCoil-XSft, 1.5x2
PENUMBRA, INC.
2016-07-30
Smart Coil - SmtCoil-XSft, 1x3
PENUMBRA, INC.
2016-07-30
Smart Coil - SmtCoil-XSft, 1x2
PENUMBRA, INC.
2016-07-30
Smart Coil - SmtCoil-XSft, 1x1.5
PENUMBRA, INC.
2016-07-30
Smart Coil - SmtCoil-XSft, 1x1
PENUMBRA, INC.
2016-07-30
Smart Coil - SmtCoil-Std, 6x20
PENUMBRA, INC.
2016-07-30
Smart Coil - SmtCoil-Std, 6x15
PENUMBRA, INC.
2016-07-30
Smart Coil - SmtCoil-Std, 5x15
PENUMBRA, INC.
2016-07-30
Smart Coil - SmtCoil-Std, 5x10
PENUMBRA, INC.
2016-07-30
Smart Coil - SmtCoil-Std, 4x8
PENUMBRA, INC.
2016-07-30
Smart Coil - SmtCoil-Std, 7x25
PENUMBRA, INC.
2016-07-30
Smart Coil - SmtCoil-Std, 8x30
PENUMBRA, INC.
2016-07-30
Smart Coil - SmtCoil-Std, 8x20
PENUMBRA, INC.
2016-07-30
Smart Coil - SmtCoil-Std, 7x15
PENUMBRA, INC.
2016-07-30
Smart Coil - SmtCoil-Std, 12x35
PENUMBRA, INC.
2016-07-30
Smart Coil - SmtCoil-Std, 11x35
PENUMBRA, INC.
2016-07-30
Smart Coil - SmtCoil-Std, 12x60
PENUMBRA, INC.
2016-07-30
Smart Coil - SmtCoil-Std, 12x45
PENUMBRA, INC.
2016-07-30

200 records. Showing 1-40. Next