FDA Registration
Active
🇺🇸 United States
MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR
Reg #: 2029214
·
FEI: 1000220862
·
Expires 2026
Products
19
Proprietary Names
98
Establishment Types
3
Classifications
19
Registration Details
- Registration Name
- MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR
- Registration Number
- 2029214
- FEI Number
- 1000220862
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 9775 Toledo Way
- City
- Irvine
- State
- CA
- ZIP
- 92618
- Country
- US
Regulatory Submissions
- 510(k) Number
- K030688
- 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 |
|---|---|---|---|---|---|
| Catheter, Continuous Flush | KRA | Class 2 | Cardiovascular | No | 2008-11-12 |
| Device, Vascular, For Promoting Embolization | KRD | Class 2 | Cardiovascular | No | 2014-02-03 |
| Device, Neurovascular Embolization | HCG | Class 2 | Neurology | No | 2014-02-03 |
| Wire, Guide, Catheter | DQX | Class 2 | Cardiovascular | No | 2012-03-05 |
| Catheter, Thrombus Retriever | NRY | Class 2 | Cardiovascular | No | 2024-10-31 |
| Agent, Injectable, Embolic | MFE | Class 3 | Unknown | No | 2014-02-05 |
| Catheter, Percutaneous | DQY | Class 2 | Cardiovascular | No | 2021-10-28 |
| Catheter, Percutaneous, Neurovasculature | QJP | Class 2 | Cardiovascular | No | 2021-10-28 |
| Guide, Wire, Catheter, Neurovasculature | MOF | Class 2 | Cardiovascular | No | 2014-02-25 |
| Catheter, Intravascular Occluding, Temporary | MJN | Class 2 | Cardiovascular | No | 2010-01-28 |
| Neurovascular Liquid Embolic Agent | SGU | Class 3 | Unknown | No | 2008-11-13 |
| Intracranial Aneurysm Flow Diverter | OUT | Class 3 | Unknown | No | 2011-05-10 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2015-02-12 |
| Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment | POL | Class 2 | Neurology | No | 2021-03-01 |
| Intrasaccular Flow Disruption Device | OPR | Class 3 | Unknown | No | 2021-05-17 |
| Intracranial Neurovascular Stent | NJE | Class f | Unknown | No | 2009-03-13 |
| Tube, Aspirating, Flexible, Connecting | BYY | Class 2 | General Hospital | No | 2026-03-12 |
| Apparatus, Suction, Ward Use, Portable, Ac-Powered | JCX | Class 2 | General, Plastic Surgery | No | 2024-12-12 |
| Catheter, Intravascular, Diagnostic | DQO | Class 2 | Cardiovascular | No | 2025-02-26 |
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
React 71 Catheter
React 68 Catheter
HyperGlide Occlusion Balloon System
HyperGlide 5mm
Phenom Catheters
Navien A+ Intracranial Catheter
ReFlex A+ Intracranial Catheter
Onyx AVM
Navien Intracranial Support Catheter
Pipeline Flex Embolization Device with Shield Technology
HyperForm Occlusion Balloon System
HyperGlide Occlusion Balloon Catheter
Onyx Syringe Catheter Interface Adapter
Rist 079 Radial Access Guide Catheter
Solitaire X Revascularization Device
Instant Detacher
Cadence Precision Injector
MTI Threaded 1 ml Syringe
APRO 55 Catheter and Alembic Aspiration Tubing
Solitaire Platinum Revascularization Device
HyperForm 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
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
Rebar Micro Catheter
FX Detachable Coil System
3G Detachable Coil System
Axium Prime Detachable Coil System
Liberant RX Large Bore Aspiration Tubing
APRO 55 Intermediate Catheter
Concerto Detachable Coil System
Concerto Versa Detachable Coil
Marksman Catheter
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 Collection Canister with Intermediate Tubing
Riptide Aspiration Pump
Riptide Tubing Kit
Riptide Aspiration System
X-pedion Hvdrophilic Guidewire
Concerto Versa Detachable Coil
Hyperglide Occlusion Balloon
Hyperform Occlusion Balloon
Rist Radial Access Catheter
Rist Radial Access Selective Catheter
X-pedion Hydrophilic Guidewire
1 ml luer lock
MTI 1ml Syringe
Echelon -14 Micro Catheter
Echelon -10 Tip ShapeMicro Catheter
Echelon -14 Tip ShapeMicro Catheter
Echelon -10 Micro Catheter
Echelon Micro Catheter
Pipeline Flex with Shield Technology
Pipeline Flex Embolization Device
Pipeline Vantage Embolization Device with Shield Technology
Marathon Micro Catheter
Phenom 27 Catheter
SOLITAIRE PLATINUM
SOLITAIRE FR REVASCULARIZATION DEVICE
SOLITAIRE FR
Pipeline Vantage Embolization Device with Shield Technology
Apro 55 Intermediate Catheter
Marathon Flow Directed Catheter
Echelon 10 Micro Catheter
Establishment Types
Manufacture Medical Device
Manufacture Device in the United States for Export Only
Complaint File Establishment per 21 CFR 820.198