FDA.reportPublic FDA data

Stryker Neurovascular

Matched from indexed company URL: STRYKER NEUROVASCULAR

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30088539773008853977Stryker Neurovascular1Y2026-01-0147900 Bayside Parkway Fremont CA US 94538
30129313453012931345Stryker Neurovascular1N2026-01-014870 West 2100 South Salt Lake City UT US 84120

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1255211799103106P180031Neuroform Atlas® Stent SystemQCA2019-05-16
2127921799103106P180031Neuroform Atlas® Stent SystemQCA2019-05-16
1255211109464444P170024Surpass Streamline Flow DiverterOUT2018-07-13
1255211945695012K994155EXCELSIOR 1018 MICROCATHETERKRA2000-08-03
1255211446669212K993418FIBERED GDC-18 VORTX SHAPE GUGLIELMI DETACHABLE COILHCG2000-01-21
1255212054080986K973645RENEGADE FIBER BRAIDED MICROCATHETERKRA1997-11-19
1255211318673495K971254TRANSEND EX PLATINUM GUIDEWIREDQX1997-07-01
1255212022467475K964611TRANSEND GUIDEWIREDQX1997-01-28
1255211373034881K934122SCIMED TRANSEND EX STEERABLE GUIDE WIRE AND ACCESSORIESDQX1993-10-07
1255211024131330K926243ANGIOGRAPHIC CATHETERDQO1993-08-16
1255211441091861K253032AXS Lift Intracranial Base CatheterQJP2026-02-11
1255211195565292K251832InZone IST Detachment System; IZDS Connecting CableHCG2025-10-17
1255211931358795K250960DUO MicrocatheterQJP2025-09-08
1255211244099102K243593AXS Lift Intracranial Base CatheterQJP2025-02-18
1255211004876062K242289Excelsior XT-27 Microcatheter, Excelsior XT-27 Flex Microcatheter, Excelsior XT-27 Pre-Shaped Microcatheter, Excelsior XT-27 Flex Pre-Shaped MicrocatheterQJP2025-03-21
1255211487777953K242243Target Detachable CoilsHCG2024-08-29
1255211819590793K241768Broadway 8 CatheterQJP2024-12-19
2127921819590793K241768Broadway 8 CatheterQJP2024-12-19
1255211204509984K241637Echo Intracranial Base CatheterQJP2024-12-19
2127921204509984K241637Echo Intracranial Base CatheterQJP2024-12-19
1255211934959946K223305Trevo NXT ProVue RetrieverPOL2023-03-29
2127921934959946K223305Trevo NXT ProVue RetrieverPOL2023-03-29
1255211808149479K222533Target Tetra Detachable CoilsHCG2022-12-14
1255211138071539K212455InZone Detachment SystemHCG2021-11-16
1255211500549756K211594Trevo Trak 21 MicrocatheterQJP2021-11-26
2127921500549756K211594Trevo Trak 21 MicrocatheterQJP2021-11-26
1255211636884177K210502Trevo NXT ProVue RetrieverPOL2021-08-27
2127921636884177K210502Trevo NXT ProVue RetrieverPOL2021-08-27
1255211052414501K203219Trevo XP ProVue Retriever and Trevo NXT™ ProVue RetrieverPOL2020-12-29
2127921052414501K203219Trevo XP ProVue Retriever and Trevo NXT™ ProVue RetrieverPOL2020-12-29
1255212063294848K202752AXS Vecta 46 Intermediate CatheterQJP2021-08-27
1255211186537087K202522Synchro SELECT GuidewireMOF2020-09-25
2127921186537087K202522Synchro SELECT GuidewireMOF2020-09-25
1255212054244974K200206AXS Vecta 71 Intermediate Catheter, AXS Vecta 74 Intermediate CatheterQJP2020-02-27
1255211837911985K200117Trevo NXT ProVue RetrieverPOL2020-02-07
2127921837911985K200117Trevo NXT ProVue RetrieverPOL2020-02-07
1255211128822312K193034AXS Infinity LS Plus Long SheathDQY2019-11-29
1255212039526675K192207Trevo NXT ProVue RetrieverPOL2019-11-22
2127922039526675K192207Trevo NXT ProVue RetrieverPOL2019-11-22
1255211612446364K192122Trevo Trak 21 MicrocatheterDQO2019-11-22
2127921612446364K192122Trevo Trak 21 MicrocatheterDQO2019-11-22
1255211740070352K191768AXS Vecta Aspiration SystemNRY2019-07-30
1255211955730986K190843Synchro2 Support GuidewireMOF2019-05-01
2127921955730986K190843Synchro2 Support GuidewireMOF2019-05-01
1255211752824080K190833AXS Vecta Aspiration CatheterDQY2019-12-15
1255211792042324K190338046 Zenith FlexNRY2019-08-02
1255212057965291K190212AXS Vecta Aspiration SystemNRY2019-04-24
1255211063925495K183464AXS Catalyst 7 Distal Access Catheter (068 x 115cm, 068 x 125cm, 068 x 132cm)NRY2019-03-13
1255211250772311K183463AXS Catalyst Distal Access Catheter 068 x 115cm, AXS Catalyst Distal Access Catheter 068 x 125cm, AXS Catalyst Distal Access Catheter 068 x 132cmDQY2019-03-13
1255212000281812K181354074 Zenith Flex SystemNRY2018-10-25
1255211047440689K173841AXS Catalyst Distal Access Catheter 058 x 115cm; AXS Catalyst Distal Access Catheter 058 x 132cm; AXS Catalyst Distal Access Catheter 060 x 132cmNRY2018-03-18
1255211483671616K173352Trevo Pro Vue Retriever and Trevo XP Pro Vue Retriever (Trevo Retriever)POL2018-02-15
2127921483671616K173352Trevo Pro Vue Retriever and Trevo XP Pro Vue Retriever (Trevo Retriever)POL2018-02-15
1255211822334000K172468091 Long Sheath, 70 cm, 091 Long Sheath, 80 cm, 091 Long Sheath, 90 cmDQY2017-12-06
1255211197501995K172167Zenith Flex SystemNRY2018-04-19
1255211389383527K163259AXS Offset Delivery Assist CatheterDQY2017-07-28
1255211857476565K161429Target Detachable CoilsHCG2016-06-22
1255211257904833K160096InZone Detachment SystemHCG2016-02-19
1255212003236737K1537298F FlowGate2 Balloon Guide CatheterDQY2016-01-27
2127922003236737K1537298F FlowGate2 Balloon Guide CatheterDQY2016-01-27
1255211762949219K153658Target Detachable CoilsHCG2016-05-19
1255211041983666K152876LONG SHEATH OR LS, 70 CM, LONG SHEATH OR LS, 80 CM, LONG SHEATH OR LS, 90 CMDQY2016-01-08
1255212014806834K151667AXS Catalyst Distal Access Catheter 058x115cm, AXS Catalyst Distal Access Catheter 058x132cm, AXS Catalyst Distal Access Catheter 060x132cmDQY2015-11-13
1255211952184539K150616Trevo XP ProVue Retriever (4x30mm)NRY2015-06-12
2127921952184539K150616Trevo XP ProVue Retriever (4x30mm)NRY2015-06-12
1255211865487532K143077Trevo XP ProVue Retriever (6X25mm)NRY2015-04-06
2127921865487532K143077Trevo XP ProVue Retriever (6X25mm)NRY2015-04-06
1255211729031426K142565Excelsior XT-17 Microcatheter, Excelsior XT-17 Flex Microcatheter, Excelsior XT-17 Pre-Shaped Microcatheter, Excelsior XT-17 Flex Pre-Shaped MicrocatheterDQY2014-11-14
1255212016711953K133177MODIFIED HD GUIDE CATHETERDQY2014-02-25
2127922016711953K133177MODIFIED HD GUIDE CATHETERDQY2014-02-25
1255211988400636K132641MODIFIED TREVO PROVUE RETRIEVERNRY2014-01-13
2127921988400636K132641MODIFIED TREVO PROVUE RETRIEVERNRY2014-01-13
1255211919957395K131437MODIFIED CONCENTRIC MICROCATHETERDQO2013-10-11
2127921919957395K131437MODIFIED CONCENTRIC MICROCATHETERDQO2013-10-11
1255211305747323K123377TARGET DETACHABLE COILHCG2012-11-30
1255211340159645K122576TRANSFORM OCCLUSION BALLOON CATHETER (COMPLIANT AND SUPER COMPLIANTMJN2013-01-11
1255211651116992K122478MODIFIED TREVO RETRIEVERNRY2012-10-31
2127921651116992K122478MODIFIED TREVO RETRIEVERNRY2012-10-31
1255211736625835K120816INZONE DETACHMENT SYSTEMKRD2012-04-17
1255211663328532K113778EXCELSIOR XT-27 MICROCATHETERDQY2012-04-20
1255211675103078K113260MODIFIED CONCENTIRC MICROCATHETERDQO2012-03-09
2127921675103078K113260MODIFIED CONCENTIRC MICROCATHETERDQO2012-03-09
1255211661800346K112404CONCENTRIC BALLOON GUIDE CATHETERDQY2012-03-15
2127921661800346K112404CONCENTRIC BALLOON GUIDE CATHETERDQY2012-03-15
1255211088555491K092666INZONE DETACHMENT SYSTEM, MODEL M00345100940, IZDS CONNECTING CABLE, MODEL M00345100250HCG2009-09-30
1255211644921780K053268PVS 2000 SYNCHRO2 GUIDEWIREDQX2006-03-13
2127921644921780K053268PVS 2000 SYNCHRO2 GUIDEWIREDQX2006-03-13
1255212034033796K050700MATRIX STRETCH RESISTANT (SR) COILSHCG2005-04-15
1255211529000652K042568EXCELSIOR 1018 AND SL-10 MICROCATHETERSDQY2004-10-15
1255211223832643K042539GDC-10 360 DEGREE COIL SR; GDC-10 360 DEGREE SOFT COIL SR; GDC-18 360 DEGREE COILHCG2004-10-19
1255211099988460K031049GUGLIELMI DETACHABLE COIL (GDC)HCG2003-08-01
1255211472566669K030475GDC STRETCH RESISTANT DETACHABLE COILHCG2003-03-14
1255211085445019K023700PVS 1600 SYNCHRO 0.010 NEURO GUIDE WIREDQX2002-12-04
2127921085445019K023700PVS 1600 SYNCHRO 0.010 NEURO GUIDE WIREDQX2002-12-04
1255211931822575K022357TRANSEND 300 ES GUIDEWIRE, MODEL 46-814 & TRANSEND 300 FLOPPY GUIDEWIRE, MODEL 46-815DQX2002-10-16
1255211119859070K013789EXCELSIOR SL-10 MICROCATHETER, MODELS 168581, 168381, 168181, 168189DQY2001-12-06
1255211210939270K010853GUIDER SOFTIP GUIDING CATHETER XF 5FDQY2001-04-18
1255211180772733K002907PVS 1300 NEURO GUIDE WIREDQX2001-03-08
2127921180772733K002907PVS 1300 NEURO GUIDE WIREDQX2001-03-08
1255211012070115K002181GDC ULTRASOFT COILHCG2000-08-11
1255211390800503K000177RENEGADE HI-FLO MICROCATHETERKRA2000-04-07
1255211342649522H050001
1255211047933528H020002
2127921047933528H020002
1255211150017867
2127921150017867
1255211547922447
2127921138071539

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DQY182019-12-15
HCG152025-10-17
NRY152019-08-02
QJP122026-02-11
POL122023-03-29
DQX102006-03-13
DQO72019-11-22
MOF42020-09-25
KRA32000-08-03
QCA22019-05-16
OUT12018-07-13
MJN12013-01-11
KRD12012-04-17

PMA#

Neuroform Atlas® Stent System

2022-11-15

Stryker Neurovascular47900 Bayside Parkwayfremont, CA 94538 PMA NumberP180031 Supplement NumberS005 Date Received09/20/2022 Decision Date11/15/2022 Product Code QCA  Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Process Change ...

PMN#