FDA Registration
Active
🇺🇸 United States
MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR
Reg #: 3015550451
·
FEI: 3015550451
·
Expires 2026
Products
17
Proprietary Names
78
Establishment Types
1
Classifications
17
Registration Details
- Registration Name
- MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR
- Registration Number
- 3015550451
- FEI Number
- 3015550451
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 5290 California Avenue
- City
- Irvine
- State
- CA
- ZIP
- 92617
- Country
- US
Regulatory Submissions
- 510(k) Number
- K133310
- PMA Number
- P030004
Owner / Operator
- Firm Name
- Medtronic, Inc.
- Operator Number
- 2112641
- Address
- 710 Medtronic Parkway
- City
- Minneapolis
- State
- MN
- Postal Code
- 55432
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Device, Vascular, For Promoting Embolization | KRD | Class 2 | Cardiovascular | No | 2014-02-03 |
| Device, Neurovascular Embolization | HCG | Class 2 | Neurology | No | 2014-02-03 |
| Catheter, Intravascular Occluding, Temporary | MJN | Class 2 | Cardiovascular | No | 2010-01-28 |
| Catheter, Continuous Flush | KRA | Class 2 | Cardiovascular | No | 2008-11-12 |
| Guide, Wire, Catheter, Neurovasculature | MOF | Class 2 | Cardiovascular | No | 2022-06-16 |
| Wire, Guide, Catheter | DQX | Class 2 | Cardiovascular | No | 2022-06-16 |
| Catheter, Percutaneous, Neurovasculature | QJP | Class 2 | Cardiovascular | No | 2020-10-14 |
| Catheter, Percutaneous | DQY | Class 2 | Cardiovascular | No | 2020-09-09 |
| Catheter, Thrombus Retriever | NRY | Class 2 | Cardiovascular | No | 2016-01-13 |
| Catheter, Intravascular, Diagnostic | DQO | Class 2 | Cardiovascular | No | 2025-02-26 |
| Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment | POL | Class 2 | Neurology | No | 2021-03-01 |
| Tube, Aspirating, Flexible, Connecting | BYY | Class 2 | General Hospital | No | 2026-03-12 |
| Neurovascular Liquid Embolic Agent | SGU | Class 3 | Unknown | No | 2008-11-13 |
| Agent, Injectable, Embolic | MFE | Class 3 | Unknown | No | 2008-11-13 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2008-11-13 |
| Apparatus, Suction, Ward Use, Portable, Ac-Powered | JCX | Class 2 | General, Plastic Surgery | No | 2024-12-12 |
| Intracranial Aneurysm Flow Diverter | OUT | Class 3 | Unknown | No | 2011-12-08 |
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
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
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
Concerto Detachable Coil System
Onyx Liquid Embolic System
Apollo Onyx Delivery Micro Catheter
Onyx AVM
Avigo¿ Hydrophilic Guidewire
1 ml luer lock
MTI 1ml Syringe
Rebar Micro Catheter
React 68 Catheter
Riptide Aspiration Pump
X-pedion Hydrophilic Guidewire
Riptide Collection Canister with Intermediate Tubing
Navien Intracranial Support Catheter
Solitaire X Revascularization Device
Echelon -14Tip Shape Micro Catheter
Echelon Tip Shape Micro Catheter
Echelon -10Tip Shape Micro Catheter
Axium Detachable Coil
Axium Prime Detachable Coil
Concerto Versa Detachable Coil
Cadence Precision Injector
MTI Threaded 1 ml Syringe
Rist 071 Radial Access Guide Catheter
Marathon Micro Catheter
X-Pedion Hydrophilic Guidewire
Axium Prime Detachable Coil System
Solitaire X
Hyperglide Occlusion Balloon
Hyperform Occlusion Balloon
Riptide Large Bore Aspiration Tubing
Pipeline Flex Embolization Device with Shield Technology
Pipeline Flex with Shield Technology
Pipeline Flex Embolization Device
Pipeline Vantage Embolization Device with Shield Technology
Riptide Aspiration System
React 68 Catheter
Solitaire FR Revascularization Device
Riptide Collection Canister with Intermediate Tubing
Riptide Aspiration Pump
Riptide Tubing Kit
Riptide Aspiration System
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility