Company · US
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
FDA 510(k) clearances and medical device recalls filed under this name, 2014 to 2025. Name variants (Inc, Corp, punctuation) are merged.
32510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| NRY | Catheter, Thrombus Retriever | 11 |
| POL | Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment | 6 |
| DQY | Catheter, Percutaneous | 5 |
| HCG | Device, Neurovascular Embolization | 4 |
| DQX | Wire, Guide, Catheter | 2 |
| JCX | Apparatus, Suction, Ward Use, Portable, Ac-Powered | 1 |
| KRA | Catheter, Continuous Flush | 1 |
| KRD | Device, Vascular, For Promoting Embolization | 1 |
| QJP | Catheter, Percutaneous, Neurovasculature | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 2, 2025 | K241388 | Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide Catheter; Rist Radial Access Selective Catheter Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | QJP |
| Dec 2, 2024 | K243418 | Riptide Aspiration Pump; Riptide Collection Canister with Intermediate Tubing Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | JCX |
| Oct 29, 2024 | K243080 | Riptide Aspiration System Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | NRY |
| Jul 27, 2021 | K211990 | Rist 071 Radial Access Guide Catheter Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | DQY |
| Jul 7, 2021 | K203432 | Axium Detachable Coil; Axium Prime Detachable Coil Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | HCG |
| Mar 1, 2021 | K203358 | Solitaire X Revascularization Device Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | POL |
| Feb 9, 2021 | K202850 | Concerto Versa, Detachable Coil Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | KRD |
| Nov 20, 2020 | K193576 | Solitaire Platinum Revascularization Device, Solitaire X Revascularization Device (Solitaire Revascularization Device) Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | POL |
| Sep 14, 2020 | K202318 | Marathon Flow Directed Micro Catheter Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | KRA |
| Jul 21, 2020 | K201690 | Mirage Hydrophilic Guidewire; X-pedion Hydrophilic Guidewire Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | DQX |
| Jul 21, 2020 | K201689 | Riptide Aspiration System Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | NRY |
| Jan 18, 2020 | K193548 | Mirage Hydrophilic Guidewire, X-pedion Hydrophilic Guidewire Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | DQX |
| Mar 6, 2019 | K181807 | Solitaire 2 Revascularization Device, Solitaire Platinum Revascularization Device (Solitaire Revascularization Device) Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | POL |
| Jan 29, 2019 | K183022 | Solitaire 4 Revascularization Device Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | POL |
| Dec 18, 2018 | K183185 | Riptide Aspiration System (Riptide Large Bore Aspiration System) Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | NRY |
| Nov 14, 2018 | K182101 | Riptide Aspiration System (React 71 Catheter) Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | NRY |
| Nov 14, 2018 | K182097 | React 71 Catheter Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | DQY |
| Oct 25, 2018 | K181186 | Solitare Platinum Revascularization Device Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | POL |
| Jul 4, 2018 | K180715 | React 68 Catheter Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | DQY |
| Jul 4, 2018 | K180705 | Riptide Aspiration System React 68 Catheter Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | NRY |
| Dec 21, 2017 | K172448 | Riptide Aspiration System Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | NRY |
| May 31, 2017 | K171268 | Reverse 021 Micro Catheter, Reverse 027 Micro Catheter Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | DQY |
| Mar 8, 2017 | K160641 | Solitaire Platinum Revascularization Device, 6x40 mm Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | NRY |
| Jan 3, 2017 | K162704 | Axium Prime Detachable Coil System Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | HCG |
| Nov 10, 2016 | K162539 | Solitaire 2 Revascularization Device Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | POL |
| Oct 12, 2016 | K161152 | Navien Intracranial Support Catheter Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | DQY |
| Sep 21, 2016 | K161879 | Solitaire Platinum Revascularization Device Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | NRY |
| Dec 23, 2015 | K153071 | Solitaire Platinum Revascularization Device Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | NRY |
| Jul 28, 2015 | K151447 | Axium Detachable Coil System Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | HCG |
| Feb 5, 2015 | K141516 | MINDFRAME CAPTURE LP REVASCULARIZATION DEVICE Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | NRY |
| Oct 22, 2014 | K141491 | SOLITAIRE 2 REVASCULARIZATION DEVICE Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | NRY |
| Jan 10, 2014 | K133310 | AXIUM DETACHABLE COIL SYSTEM Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | HCG |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||