Stryker Neurovascular

FDA Device Registration & Listing · Salt Lake City, UT, US · Registration 3012931345

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3012931345
FEI Number
3012931345
Entity Name
Stryker Neurovascular
City/State/Country
Salt Lake City, UT, US
Establishment Address
4870 West 2100 South, Salt Lake City, UT 84120, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
STRYKER CORP. (Owner Number: 1811755)
Owner / Operator Contact Address
4100 East Milham Ave., Kalamazoo, MI 49001, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K192122
PMA Number
N/A

All Registered Proprietary Names

Trevo Trak 21 Microcatheter FlowGate2 Balloon Guide Catheter, 8F Synchro2 Support Guidewire Synchro2 Guidewire Synchro-14 Guidewire Trevo NXT ProVue Retriever Broadway 8 Catheter Merci 8F Balloon Guide Catheter Merci 9F Balloon Guide Catheter Synchro-10 Guidewire Trevo Pro 18 Microcatheter Trevo NXT ProVue Retriever Synchro SELECT Guidewire Trevo NXT ProVue Retriever DAC 038 (125cm, 136cm); DAC 044 (115cm, 130cm, 136cm); DAC 057 (115cm, 125cm); DAC 070 (105cm, 120cm); Echo Intracranial Base Catheter Trevo NXT ProVue Retriever Trevo Trak 21 Microcatheter

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2022-02-04
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2022-02-04
QJP Catheter, Percutaneous, Neurovasculature Cardiovascular Class 2 870.1250 2022-02-04
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2016-02-29
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2019-06-03
MOF Guide, Wire, Catheter, Neurovasculature Cardiovascular Class 2 870.1330 2019-06-03
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2011-01-31
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2011-01-31
POL Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment Neurology Class 2 882.5600 2020-03-27
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2020-03-27
QJP Catheter, Percutaneous, Neurovasculature Cardiovascular Class 2 870.1250 2025-01-21
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2016-01-20
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2011-01-31
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2016-01-20
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2023-04-07
POL Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment Neurology Class 2 882.5600 2023-04-07
MOF Guide, Wire, Catheter, Neurovasculature Cardiovascular Class 2 870.1330 2020-10-12
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2020-10-12
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2023-04-27
POL Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment Neurology Class 2 882.5600 2023-04-27
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2016-01-20
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2016-01-20
QJP Catheter, Percutaneous, Neurovasculature Cardiovascular Class 2 870.1250 2025-01-21
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2020-03-27
POL Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment Neurology Class 2 882.5600 2020-03-27
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2020-03-27
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2020-03-27

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

STRYKER CORP.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3003897776 BIOMIMETIC THERAPEUTICS,LLC FRANKLIN, TN, US
3040801290 Inari Medical, Costa Rica S.A. Grecia Alajuela, CR
2031049 TMJ Solutions, LLC San Buenaventura, CA, US
3016573902 Ortho-Space Ltd. Caesarea Haifa, IL
3010411911 POM Medical, LLC Moorpark, CA, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K151126 Colibri Technologies, Inc. Foresight Intracardiac Echocardiography (ICE) System 2015-12-18
K931629 Carapace, Inc. CARAPACE ANGIOGRAPHY TRAYS 1993-12-06
K823758 Access Devices, Inc. CENTRAL VEIN CATHERIZATION KIT 1983-02-23
K192019 ABBOTT MEDICAL Dragonfly OpStar™ Imaging Catheter, AptiVue™ Software version E.5.1 2019-11-08
K230411 ABBOTT MEDICAL Dragonfly OpStar™ Imaging Catheter 2023-04-14

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0021-2025 Stryker Neurovascular 2
The Trevo Trak 21 Microcatheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker(s) on the distal end and a luer hub on the proximal end. The catheter shaft has a hydrophilic coating on the distal 100cm to reduce friction during use. The radiopaque shaft and distal marker(s) facilitate fluoroscopic visualization. A rotating hemostatic valve with side-arm adapter is provided with each microcatheter.
Z-0001-2010 Penumbra Inc. 2
Penumbra Neuron Delivery Catheter 070, percutaneous catheter, catalog numbers PND6F0701058, PND6F070956, PND6F0701058M, and PND6F070956M; manufactured by Penumbra, Inc., Alameda, CA. Indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
Z-0003-2014 Cordis Corporation 2
Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introduction of interventional and/or diagnostic devices into the coronary or peripheral vascular system.
Z-0009-2024 Boston Scientific Corporation 2
Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac guide catheter
Z-0010-04 Bard Peripheral Vascular 2
Conquest Balloon Dilation Catheters Model/Catalog Number CQ 75124

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012931345. Last updated year: 2026. Please use registration number 3012931345 when referencing this establishment in official correspondence.
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