Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · Predicate Candidate Screening
32 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
103 daysmedian FDA review time
241 days90th percentile
32clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K241388 | Rist 079 Radial Access Guide Catheter; Rist 071 Radial Acces | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2025-01-02 | 232 | 0 |
| K243418 | Riptide™ Aspiration Pump; Riptide™ Collection Canister with | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2024-12-02 | 28 | 0 |
| K243080 | Riptide Aspiration System | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2024-10-29 | 29 | 0 |
| K211990 | Rist 071 Radial Access Guide Catheter | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2021-07-27 | 29 | 0 |
| K203432 | Axium Detachable Coil; Axium Prime Detachable Coil | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2021-07-07 | 226 | 0 |
| K203358 | Solitaire X Revascularization Device | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2021-03-01 | 105 | 0 |
| K202850 | Concerto Versa, Detachable Coil | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2021-02-09 | 134 | 0 |
| K193576 | Solitaire Platinum Revascularization Device, Solitaire X Rev | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2020-11-20 | 333 | 0 |
| K202318 | Marathon Flow Directed Micro Catheter | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2020-09-14 | 28 | 0 |
| K201689 | Riptide Aspiration System | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2020-07-21 | 29 | 0 |
| K201690 | Mirage Hydrophilic Guidewire; X-pedion Hydrophilic Guidewire | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2020-07-21 | 29 | 0 |
| K193548 | Mirage Hydrophilic Guidewire, X-pedion Hydrophilic Guidewire | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2020-01-18 | 29 | 0 |
| K181807 | Solitaire 2 Revascularization Device, Solitaire Platinum Rev | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2019-03-06 | 243 | 0 |
| K183022 | Solitaire 4 Revascularization Device | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2019-01-29 | 89 | 0 |
| K183185 | Riptide Aspiration System (Riptide Large Bore Aspiration Sys | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2018-12-18 | 29 | 0 |
| K182101 | Riptide Aspiration System (React 71 Catheter) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2018-11-14 | 103 | 0 |
| K182097 | React 71 Catheter | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2018-11-14 | 103 | 0 |
| K181186 | Solitare Platinum Revascularization Device | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2018-10-25 | 175 | 0 |
| K180705 | Riptide Aspiration System React 68 Catheter | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2018-07-04 | 107 | 0 |
| K180715 | React 68 Catheter | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2018-07-04 | 107 | 0 |
| K172448 | Riptide Aspiration System | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2017-12-21 | 129 | 0 |
| K171268 | Reverse 021 Micro Catheter, Reverse 027 Micro Catheter | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2017-05-31 | 30 | 0 |
| K160641 | Solitaire Platinum Revascularization Device, 6x40 mm | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2017-03-08 | 366 | 0 |
| K162704 | Axium Prime Detachable Coil System | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2017-01-03 | 97 | 0 |
| K162539 | Solitaire 2 Revascularization Device | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2016-11-10 | 59 | 0 |
| K161152 | Navien Intracranial Support Catheter | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2016-10-12 | 170 | 0 |
| K161879 | Solitaire Platinum Revascularization Device | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2016-09-21 | 75 | 0 |
| K153071 | Solitaire Platinum Revascularization Device | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2015-12-23 | 62 | 0 |
| K151447 | Axium Detachable Coil System | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2015-07-28 | 60 | 0 |
| K141516 | MINDFRAME CAPTURE LP REVASCULARIZATION DEVICE | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2015-02-05 | 241 | 1 |
| K141491 | SOLITAIRE 2 REVASCULARIZATION DEVICE | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2014-10-22 | 139 | 0 |
| K133310 | AXIUM DETACHABLE COIL SYSTEM | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2014-01-10 | 74 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda