Stryker Neurovascular

FDA Device Registration & Listing · Fremont, CA, US · Registration 3008853977

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
3008853977
FEI Number
3008853977
Entity Name
Stryker Neurovascular
City/State/Country
Fremont, CA, US
Establishment Address
47900 Bayside Parkway, Fremont, CA 94538, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
STRYKER CORP. (Owner Number: 1811755)
Owner / Operator Contact Address
4100 East Milham Ave., Kalamazoo, MI 49001, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K112404
PMA Number
N/A

All Registered Proprietary Names

Trevo XP ProVue Retriever, 6x25mm InZone Detachment System Excelsior XT-17 Microcatheter Excelsior XT-17 Flex Microcatheter Gateway PTA Balloon Catheter Wingspan Stent System Excelsior 1018 Microcatheter Broadway 8 Catheter Synchro2 Support Guidewire Renegade-18 Fiber Braided Microcatheter Trevo Trak 21 Microcatheter Trevo XP ProVue Retriever, 4x30mm AXS Vecta 71 Intermediate Catheter AXS Vecta 74 Intermediate Catheter Surpass Streamline Flow Diverter Surpass Evolve Flow Diverter Surpass Elite Flow Diverter System AXS Lift Intracranial Base Catheter Excelsior SL-10 Microcatheter AXS Infinity Plus Echo Intracranial Base Catheter Excelsior XT-27 Microcatheter Trevo NXT ProVue Retriever Transend EX Guidewire with ICE Hydrophilic Coating TransForm Super Compliant Occlusion Balloon Catheter TransForm Compliant Occlusion Balloon Catheter Transend 300 Floppy Guidewire with ICE Hydrophilic Coating Transend 300 ES Guidewire with ICE Hydrophilic Coating Guidewire with ICE Hydrophilic Coating Trevo Trak 21 Microcatheter Guider Softip XF Guide Catheter AXS Universal Aspiration System (AXS Catalyst 7 Distal Access Catheter) InZone® Detachment System Target Detachable Coils AXS Vecta 74 Aspiration Catheter AXS Vecta 71 Aspiration Catheter AXS Catalyst 6 AXS Catalyst 5 AXS Vecta 74 Aspiration Catheter AXS Vecta 71 Aspiration Catheter Synchro-14 Guidewire Neuroform EZ Stent System FlowGate2 Balloon Guide Catheter, 8F AXS Vecta 46 Intermediate Catheter AXS Catalyst Distal Access Catheter Synchro SELECT Guidewire DAC 038 (125cm, 136cm); DAC 044 (115cm, 130cm, 136cm); DAC 057 (115cm, 125cm); DAC 070 (105cm, 120cm); AXS Vecta 74 Intermediate Catheter AXS Vecta 71 Intermediate Catheter AXS Lift Intracranial Base Catheter Target Tetra Detachable Coils AXS Vecta 46 Intermediate Catheter Trevo NXT ProVue Retriever Trevo XP ProVue Retriever Trevo NXT ProVue Retriever Excelsior XT-21 Microcatheter Synchro2 Guidewire 010 Guidewire with ICE Hydrophilic Coating Neuro Renegade Hi-Flo Microcatheter Trevo Pro 18 Microcatheter Trevo NXT ProVue Retriever AXS Offset Delivery Assist Catheter Merci 8F Balloon Guide Catheter Merci 9F Balloon Guide Catheter

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2016-01-20
HCG Device, Neurovascular Embolization Neurology Class 2 882.5950 2016-04-15
KRD Device, Vascular, For Promoting Embolization Cardiovascular Class 2 870.3300 2016-04-15
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2014-11-21
NJE Intracranial Neurovascular Stent Unknown Class f N/A 2011-04-01
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2011-01-31
QJP Catheter, Percutaneous, Neurovasculature Cardiovascular Class 2 870.1250 2025-01-21
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
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2017-05-12
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
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2016-01-20
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2020-07-15
QJP Catheter, Percutaneous, Neurovasculature Cardiovascular Class 2 870.1250 2020-07-15
OUT Intracranial Aneurysm Flow Diverter Unknown Class 3 N/A 2018-08-02
QJP Catheter, Percutaneous, Neurovasculature Cardiovascular Class 2 870.1250 2026-03-19
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2026-03-19
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2011-01-31
DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass Cardiovascular Class 2 870.4290 2018-07-25
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2018-07-25
GCC Dilator, Catheter General, Plastic Surgery Class 1 878.4200 2018-07-25
QJP Catheter, Percutaneous, Neurovasculature Cardiovascular Class 2 870.1250 2025-01-21
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2012-04-30
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2012-04-30
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
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2017-05-16
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2016-04-15
MJN Catheter, Intravascular Occluding, Temporary Cardiovascular Class 2 870.4450 2013-01-24
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2017-05-16
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2017-05-16
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2020-03-27
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2020-03-27
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2011-01-31
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2019-03-14
HCG Device, Neurovascular Embolization Neurology Class 2 882.5950 2022-01-24
KRD Device, Vascular, For Promoting Embolization Cardiovascular Class 2 870.3300 2022-01-24
HCG Device, Neurovascular Embolization Neurology Class 2 882.5950 2025-01-21
KRD Device, Vascular, For Promoting Embolization Cardiovascular Class 2 870.3300 2025-01-21
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2020-03-04
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2015-11-18
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2020-03-04
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2011-01-31
NJE Intracranial Neurovascular Stent Unknown Class f N/A 2011-04-01
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2016-02-29
QJP Catheter, Percutaneous, Neurovasculature Cardiovascular Class 2 870.1250 2021-11-30
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2018-04-16
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2018-04-16
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
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2016-01-20
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2016-01-20
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2020-07-15
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2025-02-27
QJP Catheter, Percutaneous, Neurovasculature Cardiovascular Class 2 870.1250 2025-02-27
KRD Device, Vascular, For Promoting Embolization Cardiovascular Class 2 870.3300 2022-12-15
HCG Device, Neurovascular Embolization Neurology Class 2 882.5950 2022-12-15
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2021-11-30
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
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
QJP Catheter, Percutaneous, Neurovasculature Cardiovascular Class 2 870.1250 2026-03-19
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2026-03-19
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2026-03-19
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2011-01-31
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2017-05-16
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2017-05-12
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2016-01-20
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
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2017-11-29
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2016-01-20

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
K033736 Concentric Medical, Inc. MERCI RETRIEVER, MODELS 90065, 90066 2004-08-11
K951256 Target Therapeutics DETACHABLE PLATINUM COIL (GUGLIELMI DETACHABLE COIL, GDC) 1995-09-08
K043580 Chestnut Medical Technologies, Inc. ALLIGATOR RETRIEVAL DEVICE (ARD) 2005-03-24
K982883 Medtronics Interventional Vascular MEDTRONIC 7F AND 8F ZUMA GUIDING CATHETER 1998-09-04
K132420 Reflow Medical WINGMAN EXTENDABLE TIP SUPPORT CATHETER 2013-09-19

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 3008853977. Last updated year: 2026. Please use registration number 3008853977 when referencing this establishment in official correspondence.
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