MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR

FDA Device Registration & Listing · Irvine, CA, US · Registration 2029214

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
2029214
FEI Number
1000220862
Entity Name
MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR
City/State/Country
Irvine, CA, US
Establishment Address
9775 Toledo Way, Irvine, CA 92618, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Medtronic, Inc. (Owner Number: 2112641)
Owner / Operator Contact Address
710 Medtronic Parkway, Minneapolis, MN 55432, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K201689
PMA Number
N/A

All Registered Proprietary Names

Echelon 14 Micro Catheter Rebar Micro Catheter Axium Detachable Coil System Avigo¿ Hydrophilic Guidewire Riptide™ Large Bore Aspiration Tubing Riptide™ Aspiration System React™ 71 Catheter Riptide™ Collection Canister with Intermediate Tubing React™ 68 Catheter Riptide™ Aspiration Pump Onyx Liquid Embolic System Apollo Onyx Delivery Micro Catheter Rist™ 071 Radial Access Guide Catheter APRO 70 Catheter and Alembic Aspiration Tubing Mirage Hydrophilic Guidewire X-Pedion Hydrophilic Guidewire APRO 70 Swift Catheter and Alembic Aspiration Tubing Axium Detachable Coil System React 71 Catheter React 68 Catheter HyperGlide Occlusion Balloon System HyperGlide 5mm Phenom Catheters Navien A+ Intracranial Catheter ReFlex A+ Intracranial Catheter Onyx Liquid Embolic System Apollo Onyx Delivery Micro Catheter Onyx AVM Navien Intracranial Support Catheter Pipeline Flex Embolization Device with Shield Technology HyperForm Occlusion Balloon System HyperGlide Occlusion Balloon System HyperGlide Occlusion Balloon Catheter Onyx Syringe Catheter Interface Adapter React 68 Catheter Rist™ 079 Radial Access Guide Catheter Solitaire X Revascularization Device Instant Detacher Axium Detachable Coil System Cadence Precision Injector MTI Threaded 1 ml Syringe HyperForm Occlusion Balloon System APRO 55 Catheter and Alembic Aspiration Tubing Solitaire™ Platinum Revascularization Device HyperForm Occlusion Balloon Catheter HyperGlide Occlusion Balloon Catheter Axium™ Detachable Coil Axium™ Prime Detachable Coil Echelon -14Tip Shape Micro Catheter Echelon Tip Shape Micro Catheter Echelon -10Tip Shape Micro Catheter Tip Shape Echelon Micro Catheter Mirage Hydrophilic Guidewire Solitaire Platinum Revascularization Device Solitaire Platinum Revascularization Device APRO 70 Swift Catheter Artisse Detachment Device Artisse Intrasaccular Device Solitaire™ X Revascularization Device Solitaire X Solitaire AB Solitaire AB Neurovascular Remodeling Device Solitaire Detachment System Solitaire FR Revascularization Device HyperGlide Occlusion Balloon System Rebar™ Micro Catheter FX Detachable Coil System 3G Detachable Coil System Axium Detachable Coil System Instant Detacher Axium Detachable Coil System Axium Prime Detachable Coil System Liberant™ RX Large Bore Aspiration Tubing APRO 55 Intermediate Catheter Concerto Detachable Coil System Rebar Micro Catheter Concerto Versa Detachable Coil Marksman Catheter Solitaire Platinum Revascularization Device Riptide™ Collection Canister with Intermediate Tubing Riptide™ Aspiration Pump Rist 071 Radial Access Guide Catheter Rist Radial Access Selective Catheter Rist 079 Radial Access Guide Catheter APRO 55 Swift Catheter And Alembic Aspiration Tubing Axium Prime Detachable Coil System (FitzRoy) Riptide™ Aspiration Pump

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2008-11-12
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2008-11-13
KRD Device, Vascular, For Promoting Embolization Cardiovascular Class 2 870.3300 2014-02-03
HCG Device, Neurovascular Embolization Neurology Class 2 882.5950 2014-02-03
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2012-03-05
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2024-10-31
MFE Agent, Injectable, Embolic Unknown Class 3 N/A 2014-02-05
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2021-10-28
QJP Catheter, Percutaneous, Neurovasculature Cardiovascular Class 2 870.1250 2021-10-28
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2023-03-30
MOF Guide, Wire, Catheter, Neurovasculature Cardiovascular Class 2 870.1330 2014-02-25
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2014-02-25
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2025-02-26
KRD Device, Vascular, For Promoting Embolization Cardiovascular Class 2 870.3300 2015-08-13
HCG Device, Neurovascular Embolization Neurology Class 2 882.5950 2015-08-13
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2018-11-26
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2018-07-09
MJN Catheter, Intravascular Occluding, Temporary Cardiovascular Class 2 870.4450 2010-01-28
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2016-02-15
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2016-02-15
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2012-01-23
SGU Neurovascular Liquid Embolic Agent Unknown Class 3 N/A 2008-11-13
MFE Agent, Injectable, Embolic Unknown Class 3 N/A 2008-11-13
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2012-01-23
OUT Intracranial Aneurysm Flow Diverter Unknown Class 3 N/A 2011-05-10
MJN Catheter, Intravascular Occluding, Temporary Cardiovascular Class 2 870.4450 2015-11-05
MJN Catheter, Intravascular Occluding, Temporary Cardiovascular Class 2 870.4450 2010-01-28
FMF Syringe, Piston General Hospital Class 2 880.5860 2015-02-12
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2018-07-09
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2020-09-09
POL Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment Neurology Class 2 882.5600 2021-03-01
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2021-03-01
KRD Device, Vascular, For Promoting Embolization Cardiovascular Class 2 870.3300 2008-11-12
MJN Catheter, Intravascular Occluding, Temporary Cardiovascular Class 2 870.4450 2008-11-13
MJN Catheter, Intravascular Occluding, Temporary Cardiovascular Class 2 870.4450 2008-11-13
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2024-03-20
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2019-07-12
POL Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment Neurology Class 2 882.5600 2019-07-12
MJN Catheter, Intravascular Occluding, Temporary Cardiovascular Class 2 870.4450 2010-01-28
KRD Device, Vascular, For Promoting Embolization Cardiovascular Class 2 870.3300 2023-11-10
HCG Device, Neurovascular Embolization Neurology Class 2 882.5950 2023-11-10
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2008-11-12
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2008-11-13
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2016-12-15
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2017-03-09
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2026-03-24
QJP Catheter, Percutaneous, Neurovasculature Cardiovascular Class 2 870.1250 2026-03-24
OPR Intrasaccular Flow Disruption Device Unknown Class 3 N/A 2021-05-17
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2019-02-20
POL Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment Neurology Class 2 882.5600 2019-02-20
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2019-04-19
POL Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment Neurology Class 2 882.5600 2019-04-19
NJE Intracranial Neurovascular Stent Unknown Class f N/A 2009-03-13
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2012-03-05
MJN Catheter, Intravascular Occluding, Temporary Cardiovascular Class 2 870.4450 2008-11-12
QJP Catheter, Percutaneous, Neurovasculature Cardiovascular Class 2 870.1250 2021-02-18
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2021-02-18
HCG Device, Neurovascular Embolization Neurology Class 2 882.5950 2008-11-12
HCG Device, Neurovascular Embolization Neurology Class 2 882.5950 2021-08-30
KRD Device, Vascular, For Promoting Embolization Cardiovascular Class 2 870.3300 2021-08-30
BYY Tube, Aspirating, Flexible, Connecting General Hospital Class 2 880.6740 2026-03-12
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2024-03-20
QJP Catheter, Percutaneous, Neurovasculature Cardiovascular Class 2 870.1250 2024-03-20
KRD Device, Vascular, For Promoting Embolization Cardiovascular Class 2 870.3300 2009-03-13
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2008-11-13
KRD Device, Vascular, For Promoting Embolization Cardiovascular Class 2 870.3300 2021-02-10
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2009-10-29
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2016-01-13
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2024-12-12
JCX Apparatus, Suction, Ward Use, Portable, Ac-Powered General, Plastic Surgery Class 2 878.4780 2024-12-12
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2025-02-26
QJP Catheter, Percutaneous, Neurovasculature Cardiovascular Class 2 870.1250 2025-02-26
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2025-02-26
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2025-06-24
HCG Device, Neurovascular Embolization Neurology Class 2 882.5950 2017-01-24
KRD Device, Vascular, For Promoting Embolization Cardiovascular Class 2 870.3300 2017-01-24
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2020-10-14

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

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

Other Registrations for Same Entity

Registration Number Establishment Name Location
3007042319 HeartWare, Inc. Miami Lakes, FL, US
3004497303 MEDTRONIC MEXICO EG EMPALME Sonora, MX
3015192387 CATHWORKS Newport Beach, CA, US
3004185781 Medtronic, Inc. Tempe, AZ, US
3012520654 MEDTRONIC, INC. Billerica, MA, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K103464 Medtronic, Inc. PACIFIC XTREME PTCA BALLOON DILATATION CATHETER 2010-12-22
K111339 Medtronic, Inc. HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS) 2011-06-08
K792141 Pharmaseal Div., Baxter Healthcare Corp. CONTINUOUS FLUSH DEVICE 1979-12-05
K924661 Baxter Healthcare Corp SWAN-GANZ INTELLICATH CCO THERMODILUTION CATHETER 1993-04-08
K951256 Target Therapeutics DETACHABLE PLATINUM COIL (GUGLIELMI DETACHABLE COIL, GDC) 1995-09-08

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0030-2009 Boston Scientific Corporation 2
Platinum Plus" LT , REF 46-601, UPN M001466010, LT/0.018/180, Sterilized with ethylene oxide gas, Rx only, Legal Manufacturer Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, Made in USA: 8600 NW 41st Street, Miami, FL 33166-6202. The Platinum Plus" Guidewire facilitates placement of a catheter during diagnostic or interventional intravascular procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches.
Z-0031-2009 Boston Scientific Corporation 2
Platinum Plus" LT , REF 46-602, UPN M001466020, LT/0.018/260, Sterilized with ethylene oxide gas, Rx only, Legal Manufacturer Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, Made in USA: 8600 NW 41st Street, Miami, FL 33166-6202. The Platinum Plus" Guidewire facilitates placement of a catheter during diagnostic or interventional intravascular procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches.
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2029214. Last updated year: 2026. Please use registration number 2029214 when referencing this establishment in official correspondence.
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