MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR

FDA Device Registration & Listing · Irvine, CA, US · Registration 3015550451

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
3015550451
FEI Number
3015550451
Entity Name
MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR
City/State/Country
Irvine, CA, US
Establishment Address
5290 California Avenue, Irvine, CA 92617, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
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
K162539
PMA Number
N/A

All Registered Proprietary Names

Axium Detachable Coil System HyperGlide Occlusion Balloon System HyperGlide 5mm Echelon 14 Micro Catheter X-pedion Hvdrophilic Guidewire Mirage Hydrophilic Guidewire Marathon™ Flow Directed Catheter Rist™ Radial Access Catheter Rist™ Radial Access Selective Catheter HyperForm Occlusion Balloon Catheter HyperGlide Occlusion Balloon Catheter FX Detachable Coil System 3G Detachable Coil System Axium Detachable Coil System Instant Detacher Solitaire Platinum Revascularization Device Rist 071 Radial Access Guide Catheter Rist Radial Access Selective Catheter Rist 079 Radial Access Guide Catheter Solitaire X Revascularization Device Echelon -14 Micro Catheter Echelon -10 Tip ShapeMicro Catheter Echelon -14 Tip ShapeMicro Catheter Echelon -10 Micro Catheter Tip Shape Echelon Micro Catheter Echelon Micro Catheter HyperForm Occlusion Balloon System HyperGlide Occlusion Balloon System Axium Prime Detachable Coil System (FitzRoy) React™ 71 Catheter Phenom™ 27 Catheter Phenom Catheters Rebar Micro Catheter Marksman Catheter Rist™ 079 Radial Access Guide Catheter Solitaire™ Platinum Revascularization Device Liberant™ RX Large Bore Aspiration Tubing Echelon 10 Micro Catheter React 71 Catheter Rist™ Radial Access Catheter Rist™ Radial Access Selective Catheter Concerto Detachable Coil System Solitaire Platinum Revascularization Device Onyx Liquid Embolic System Apollo Onyx Delivery Micro Catheter Onyx AVM Avigo¿ Hydrophilic Guidewire Mirage Hydrophilic Guidewire 1 ml luer lock MTI 1ml Syringe Rebar™ Micro Catheter React 68 Catheter Riptide™ Aspiration Pump Rebar Micro Catheter X-pedion Hydrophilic Guidewire Mirage Hydrophilic Guidewire HyperGlide Occlusion Balloon System React 71 Catheter Riptide™ Collection Canister with Intermediate Tubing Riptide™ Aspiration Pump Navien Intracranial Support Catheter Solitaire™ X Revascularization Device Solitaire™ Platinum Revascularization Device Echelon -14Tip Shape Micro Catheter Echelon Tip Shape Micro Catheter Echelon -10Tip Shape Micro Catheter Tip Shape Echelon Micro Catheter Axium™ Detachable Coil Axium™ Prime Detachable Coil Solitaire Platinum Revascularization Device Instant Detacher Axium Detachable Coil System Concerto Versa Detachable Coil Cadence Precision Injector MTI Threaded 1 ml Syringe Solitaire™ Platinum Revascularization Device

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
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
MJN Catheter, Intravascular Occluding, Temporary Cardiovascular Class 2 870.4450 2010-01-28
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2008-11-12
MOF Guide, Wire, Catheter, Neurovasculature Cardiovascular Class 2 870.1330 2022-06-16
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2022-06-16
QJP Catheter, Percutaneous, Neurovasculature Cardiovascular Class 2 870.1250 2020-10-14
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2020-10-14
QJP Catheter, Percutaneous, Neurovasculature Cardiovascular Class 2 870.1250 2020-09-09
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2020-09-09
MJN Catheter, Intravascular Occluding, Temporary Cardiovascular Class 2 870.4450 2010-01-28
HCG Device, Neurovascular Embolization Neurology Class 2 882.5950 2008-11-12
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2016-01-13
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
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
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2008-11-12
MJN Catheter, Intravascular Occluding, Temporary Cardiovascular Class 2 870.4450 2015-11-05
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
QJP Catheter, Percutaneous, Neurovasculature Cardiovascular Class 2 870.1250 2024-05-29
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2024-05-29
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2018-07-17
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2018-07-17
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2021-03-03
QJP Catheter, Percutaneous, Neurovasculature Cardiovascular Class 2 870.1250 2021-03-03
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2021-03-03
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2008-11-13
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2009-10-29
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 2019-02-20
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2019-02-20
BYY Tube, Aspirating, Flexible, Connecting General Hospital Class 2 880.6740 2026-03-12
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2008-11-12
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2018-11-26
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2020-12-03
QJP Catheter, Percutaneous, Neurovasculature Cardiovascular Class 2 870.1250 2020-12-03
KRD Device, Vascular, For Promoting Embolization Cardiovascular Class 2 870.3300 2009-03-13
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2017-03-09
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
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2012-03-05
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2008-11-13
FMF Syringe, Piston General Hospital Class 2 880.5860 2008-11-13
QJP Catheter, Percutaneous, Neurovasculature Cardiovascular Class 2 870.1250 2021-02-18
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2021-02-18
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2018-07-09
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2020-10-14
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2008-11-13
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2020-07-21
MOF Guide, Wire, Catheter, Neurovasculature Cardiovascular Class 2 870.1330 2020-07-21
MJN Catheter, Intravascular Occluding, Temporary Cardiovascular Class 2 870.4450 2008-11-12
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2018-11-26
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
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2012-01-23
POL Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment Neurology Class 2 882.5600 2021-05-24
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2021-05-24
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2008-11-12
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
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2016-12-15
KRD Device, Vascular, For Promoting Embolization Cardiovascular Class 2 870.3300 2008-11-12
KRD Device, Vascular, For Promoting Embolization Cardiovascular Class 2 870.3300 2021-02-10
MJN Catheter, Intravascular Occluding, Temporary Cardiovascular Class 2 870.4450 2008-11-13
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

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
K951256 Target Therapeutics DETACHABLE PLATINUM COIL (GUGLIELMI DETACHABLE COIL, GDC) 1995-09-08
K051067 LeMaitre Vascular, Inc. PRUITT F3 OUTLYING AND INLYING CAROTID SHUNT (WITH AND WITHOUT T-PORT) 2005-05-27
K093847 Thermopeutix, Inc. DUFLO CATHETER (HEPARIN COATED) 2010-08-25

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0013-2009 Edwards Lifesciences, LLC 2
Edwards Lifesciences***Fogarty Fortis***Arterial Embolectomy Catheter Is indicated for the removal of fresh, soft emboli and thrombi from the vessels in the arterial system.
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-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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015550451. Last updated year: 2026. Please use registration number 3015550451 when referencing this establishment in official correspondence.
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