Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
Irvine, CA, US
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular appears in FDA device records in Irvine, CA. FDA records list 32 510(k) clearances between and , 52 PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 32
- PMA records
- 52
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 32 510(k) clearances for Micro Therapeutics, Inc. d/b/a ev3 Neurovascular between 2014 and 2025. The busiest year on record is 2018, with 6. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2014 | 2 |
| 2015 | 3 |
| 2016 | 3 |
| 2017 | 4 |
| 2018 | 6 |
| 2019 | 2 |
| 2020 | 5 |
| 2021 | 4 |
| 2024 | 2 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K241388 | Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide Catheter; Rist Radial Access Selective Catheter | QJP | Substantially Equivalent | |
| K243418 | Riptide™ Aspiration Pump; Riptide™ Collection Canister with Intermediate Tubing | JCX | Substantially Equivalent | |
| K243080 | Riptide Aspiration System | NRY | Substantially Equivalent | |
| K211990 | Rist 071 Radial Access Guide Catheter | DQY | Substantially Equivalent | |
| K203432 | Axium Detachable Coil; Axium Prime Detachable Coil | HCG | Substantially Equivalent | |
| K203358 | Solitaire X Revascularization Device | POL | Substantially Equivalent | |
| K202850 | Concerto Versa, Detachable Coil | KRD | Substantially Equivalent | |
| K193576 | Solitaire Platinum Revascularization Device, Solitaire X Revascularization Device (Solitaire Revascularization Device) | POL | Substantially Equivalent | |
| K202318 | Marathon Flow Directed Micro Catheter | KRA | Substantially Equivalent | |
| K201690 | Mirage Hydrophilic Guidewire; X-pedion Hydrophilic Guidewire | DQX | Substantially Equivalent | |
| K201689 | Riptide Aspiration System | NRY | Substantially Equivalent | |
| K193548 | Mirage Hydrophilic Guidewire, X-pedion Hydrophilic Guidewire | DQX | Substantially Equivalent | |
| K181807 | Solitaire 2 Revascularization Device, Solitaire Platinum Revascularization Device (Solitaire Revascularization Device) | POL | Substantially Equivalent | |
| K183022 | Solitaire 4 Revascularization Device | POL | Substantially Equivalent | |
| K183185 | Riptide Aspiration System (Riptide Large Bore Aspiration System) | NRY | Substantially Equivalent | |
| K182101 | Riptide Aspiration System (React 71 Catheter) | NRY | Substantially Equivalent | |
| K182097 | React 71 Catheter | DQY | Substantially Equivalent | |
| K181186 | Solitare Platinum Revascularization Device | POL | Substantially Equivalent | |
| K180715 | React 68 Catheter | DQY | Substantially Equivalent | |
| K180705 | Riptide Aspiration System React 68 Catheter | NRY | Substantially Equivalent | |
| K172448 | Riptide Aspiration System | NRY | Substantially Equivalent | |
| K171268 | Reverse 021 Micro Catheter, Reverse 027 Micro Catheter | DQY | Substantially Equivalent | |
| K160641 | Solitaire Platinum Revascularization Device, 6x40 mm | NRY | Substantially Equivalent | |
| K162704 | Axium Prime Detachable Coil System | HCG | Substantially Equivalent | |
| K162539 | Solitaire 2 Revascularization Device | POL | Substantially Equivalent | |
| K161152 | Navien Intracranial Support Catheter | DQY | Substantially Equivalent | |
| K161879 | Solitaire Platinum Revascularization Device | NRY | Substantially Equivalent | |
| K153071 | Solitaire Platinum Revascularization Device | NRY | Substantially Equivalent | |
| K151447 | Axium Detachable Coil System | HCG | Substantially Equivalent | |
| K141516 | MINDFRAME CAPTURE LP REVASCULARIZATION DEVICE | NRY | Substantially Equivalent | |
| K141491 | SOLITAIRE 2 REVASCULARIZATION DEVICE | NRY | Substantially Equivalent | |
| K133310 | AXIUM DETACHABLE COIL SYSTEM | HCG | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- JCXApparatus, Suction, Ward Use, Portable, Ac-Powered
- KRACatheter, Continuous Flush
- DQYCatheter, Percutaneous
- QJPCatheter, Percutaneous, Neurovasculature
- NRYCatheter, Thrombus Retriever
- HCGDevice, Neurovascular Embolization
- KRDDevice, Vascular, For Promoting Embolization
- OUTIntracranial Aneurysm Flow Diverter
- POLNeurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment
- DQXWire, Guide, Catheter
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain