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Data / Medical devices / United States / Stryker Neurovascular

Stryker Neurovascular: FDA-registered device maker in Salt Lake City, UT, United States, 21 510(k) clearances

Stryker Neurovascular is registered with the FDA (registration 3012931345) in Salt Lake City, UT, United States. It lists 9 device types. The FDA files 21 510(k) clearances under its listings, the newest dated December 19, 2024. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Stryker Neurovascular
FDA registration number
3012931345
Address
4870 West 2100 South, Salt Lake City, UT, United States, 84120
Owner or operator
STRYKER CORP. (1811755)
Roles
Contract sterilizer, Manufacturer
First device listed
January 31, 2011
Registered through
2027
Brand names listed
Broadway 8 Catheter, DAC 038 (125cm, 136cm); DAC 044 (115cm, 130cm, 136cm); DAC 057 (115cm, 125cm); DAC 070 (105cm, 120cm);, Echo Intracranial Base Catheter, FlowGate2 Balloon Guide Catheter, 8F, InZone® Detachment System, Merci 8F Balloon Guide Catheter, Merci 9F Balloon Guide Catheter, Synchro SELECT Guidewire and more

Devices it lists

DeviceProduct codeClassRoleSource
Catheter, Intravascular, DiagnosticDQO2Manufactureraccessdata.fda.gov
Catheter, PercutaneousDQY2Manufactureraccessdata.fda.gov
Catheter, Percutaneous, NeurovasculatureQJP2Manufactureraccessdata.fda.gov
Catheter, Thrombus RetrieverNRY2Manufactureraccessdata.fda.gov
Device, Neurovascular EmbolizationHCG2Contract sterilizeraccessdata.fda.gov
Device, Vascular, For Promoting EmbolizationKRD2Contract sterilizeraccessdata.fda.gov
Guide, Wire, Catheter, NeurovasculatureMOF2Manufactureraccessdata.fda.gov
Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke TreatmentPOL2Manufactureraccessdata.fda.gov
Wire, Guide, CatheterDQX2Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
December 19, 2024K241768Broadway 8 CatheterQJPSubstantially EquivalentStryker Neurovascularaccessdata.fda.gov
December 19, 2024K241637Echo Intracranial Base CatheterQJPSubstantially EquivalentStryker Neurovascularaccessdata.fda.gov
March 29, 2023K223305Trevo NXT ProVue RetrieverPOLSubstantially EquivalentStryker Neurovascularaccessdata.fda.gov
November 26, 2021K211594Trevo Trak 21 MicrocatheterQJPSubstantially EquivalentStryker Neurovascularaccessdata.fda.gov
August 27, 2021K210502Trevo NXT ProVue RetrieverPOLSubstantially EquivalentStryker Neurovascularaccessdata.fda.gov
December 29, 2020K203219Trevo XP ProVue Retriever and Trevo NXT™ ProVue RetrieverPOLSubstantially EquivalentStryker Neurovascularaccessdata.fda.gov
September 25, 2020K202522Synchro SELECT GuidewireMOFSubstantially EquivalentStryker Neurovascularaccessdata.fda.gov
February 7, 2020K200117Trevo NXT ProVue RetrieverPOLSubstantially EquivalentStrykeraccessdata.fda.gov
November 22, 2019K192207Trevo NXT ProVue RetrieverPOLSubstantially EquivalentStrykeraccessdata.fda.gov
November 22, 2019K192122Trevo Trak 21 MicrocatheterDQOSubstantially EquivalentStrykeraccessdata.fda.gov
May 1, 2019K190843Synchro2 Support GuidewireMOFSubstantially EquivalentStrykeraccessdata.fda.gov
January 27, 2016K1537298F FlowGate2 Balloon Guide CatheterDQYSubstantially EquivalentConcentric Medicalaccessdata.fda.gov
June 12, 2015K150616Trevo XP ProVue Retriever (4x30mm)NRYSubstantially EquivalentConcentric Medical, Inc.accessdata.fda.gov
April 6, 2015K143077Trevo XP ProVue Retriever (6X25mm)NRYSubstantially EquivalentConcentric Medical, Inc.accessdata.fda.gov
February 25, 2014K133177MODIFIED HD GUIDE CATHETERDQYSubstantially EquivalentConcentric Medical, Inc.accessdata.fda.gov
January 13, 2014K132641MODIFIED TREVO PROVUE RETRIEVERNRYSubstantially EquivalentConcentric Medical, Inc.accessdata.fda.gov
March 15, 2012K112404CONCENTRIC BALLOON GUIDE CATHETERDQYSubstantially EquivalentConcentric Medical, Inc.accessdata.fda.gov
March 9, 2012K113260MODIFIED CONCENTIRC MICROCATHETERDQOSubstantially EquivalentConcentric Medical, Inc.accessdata.fda.gov
March 13, 2006K053268PVS 2000 SYNCHRO2 GUIDEWIREDQXSubstantially EquivalentBoston Scientific - Precision Vascularaccessdata.fda.gov
December 4, 2002K023700PVS 1600 SYNCHRO 0.010 NEURO GUIDE WIREDQXSubstantially EquivalentPrecision Vascular Systems, Inc.accessdata.fda.gov
March 8, 2001K002907PVS 1300 NEURO GUIDE WIREDQXSubstantially EquivalentPrecision Vascular Systems, Inc.accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
December 6, 202393678Class IIOngoingStryker Neurovascular, Trevo Pro 18 Microcatheter, REF 90238 0.021in X150cmThe microcatheter IFU contains an intended use that has not been evaluated by the FDA.accessdata.fda.gov

Compare with other makers

Updated December 19, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.