Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MicroVention, Inc. — Predicate Candidate Screening
85 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
91 daysmedian FDA review time
237 days90th percentile
85clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K232542 | Wedge XL Delivery Catheter | MicroVention, Inc. | 2024-05-16 | 268 | 0 |
| K230775 | SOFIA EX Intracranial Support Catheter | MicroVention, Inc. | 2023-09-14 | 177 | 0 |
| K222694 | EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP451 | MicroVention, Inc. | 2023-04-27 | 233 | 0 |
| K222115 | ISAAC Neurovascular Navigation Catheter | MicroVention, Inc. | 2023-01-10 | 176 | 0 |
| K223050 | AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-88003 | MicroVention, Inc. | 2022-12-21 | 83 | 0 |
| K214024 | SOFIA 88 Catheter | MicroVention, Inc. | 2022-09-12 | 264 | 0 |
| K211120 | ERIC Retrieval Device | MicroVention, Inc. | 2022-03-31 | 350 | 1 |
| K193607 | BOBBY Balloon Guide Catheter | MicroVention, Inc. | 2020-07-21 | 208 | 1 |
| K201487 | Traxcess 7 Mini Guidewire | MicroVention, Inc. | 2020-07-02 | 28 | 0 |
| K200547 | Traxcess 14 SELECT Guidewire | MicroVention, Inc. | 2020-04-16 | 44 | 0 |
| K191680 | AZUR Vascular Plug | MicroVention, Inc. | 2020-03-20 | 270 | 0 |
| K192684 | HydroPearl Microspheres | MicroVention, Inc. | 2020-01-22 | 118 | 1 |
| K192135 | VIA Microcatheter (size 17), VIA Microcatheter (size 21), VI | MicroVention, Inc. | 2019-12-24 | 139 | 0 |
| K182829 | Scepter Mini Occlusion Balloon Catheter | MicroVention, Inc. | 2019-07-10 | 278 | 0 |
| K182602 | SOFIA EX Intracranial Support Catheter | MicroVention, Inc. | 2019-05-15 | 236 | 0 |
| K173200 | SOFIA Plus Aspiration Catheter | MicroVention, Inc. | 2018-06-11 | 252 | 0 |
| K172014 | Wedge Microcatheter | MicroVention, Inc. | 2018-04-05 | 276 | 0 |
| K162999 | V-Grip Detachment Controller for use with Hydrocoil Embolic | MicroVention, Inc. | 2017-03-29 | 152 | 0 |
| K162524 | AZUR CX Detachable 18 Peripheral Coil System | MicroVention, Inc. | 2017-03-03 | 175 | 0 |
| K163154 | Traxcess 7 Mini XSoft Guidewire | MicroVention, Inc. | 2016-12-09 | 29 | 0 |
| K161803 | Traxcess .007 Mini Guidewire | MicroVention, Inc. | 2016-09-30 | 92 | 0 |
| K161367 | HydroCoil Embolic System (HES) | MicroVention, Inc. | 2016-08-31 | 106 | 0 |
| K161452 | MicroPlex Coil System (MCS) - HyperSoft 3D | MicroVention, Inc. | 2016-08-31 | 97 | 0 |
| K153594 | MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES) | MicroVention, Inc. | 2016-01-22 | 37 | 0 |
| K153053 | Traxcess Pro 14 Guidewire | MicroVention, Inc. | 2015-12-29 | 70 | 0 |
| K150870 | HydroPearl Microspheres, HydroPearl Microspheres | MicroVention, Inc. | 2015-12-21 | 264 | 1 |
| K151358 | AZUR CX Detachable 35 Coils | MicroVention, Inc. | 2015-09-25 | 128 | 1 |
| K150958 | LifePearl Microshperes | MicroVention, Inc. | 2015-09-17 | 161 | 1 |
| K150366 | SOFIA 6F Catheter | MicroVention, Inc. | 2015-03-27 | 43 | 0 |
| K142449 | Headway 27 Microcatheter | MicroVention, Inc. | 2015-03-26 | 205 | 0 |
| K142014 | SOFIA DISTAL ACCESS CATHETER | MicroVention, Inc. | 2014-10-10 | 78 | 0 |
| K133725 | TRAXCESS 14 GUIDEWIRE | MicroVention, Inc. | 2014-07-31 | 237 | 0 |
| K133626 | AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 35 | MicroVention, Inc. | 2013-12-20 | 24 | 0 |
| K132952 | MICROPLEX COIL SYSTEM (MCS), HYDROCOIL EMBOLIC SYSTEM (HES) | MicroVention, Inc. | 2013-12-19 | 91 | 0 |
| K131482 | SOFIA DISTAL ACCESS CATHETER | MicroVention, Inc. | 2013-11-22 | 183 | 0 |
| K132083 | AZUR PURE PERIPHERAL COIL SYSTEMS, PUSHABLE 35 | MicroVention, Inc. | 2013-10-28 | 115 | 0 |
| K131948 | MICROPLEX COIL SYSTEM (MCS) | MicroVention, Inc. | 2013-10-04 | 99 | 0 |
| K132317 | MICROPLEX COIL SYSTEM (MCS), VFC | MicroVention, Inc. | 2013-09-20 | 57 | 0 |
| K130577 | AZUR PUSHABLE 18 & 35 SYSTEM | MicroVention, Inc. | 2013-06-17 | 104 | 0 |
| K123384 | AZUR CX DETACHABLE 18 | MicroVention, Inc. | 2012-11-28 | 26 | 0 |
| K122543 | AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 18 AZUR PURE PERI | MicroVention, Inc. | 2012-11-28 | 99 | 0 |
| K122316 | AZUR DETACHABLE 35 | MicroVention, Inc. | 2012-08-29 | 28 | 0 |
| K121785 | SCEPTER C OCCLUSION BALLOON CATHETER | MicroVention, Inc. | 2012-08-10 | 53 | 0 |
| K120917 | HEADWAY DUO MICROCATHETER | MicroVention, Inc. | 2012-08-02 | 128 | 0 |
| K120908 | HYDROCOIL EMBOLIC SYSTEM (HES) | MicroVention, Inc. | 2012-04-25 | 30 | 0 |
| K120630 | AZUR DETACHABLE 18 | MicroVention, Inc. | 2012-03-28 | 27 | 0 |
| K113698 | SCEPTER XC OCCLUSION BALLOON CATHETER | MicroVention, Inc. | 2012-01-13 | 28 | 0 |
| K113457 | HYDROCOIL EMBOLIC SYSTEM (HES) | MicroVention, Inc. | 2011-12-16 | 24 | 0 |
| K112181 | HYDROCOIL(R) EMBOLIC SYSTEM (HES) | MicroVention, Inc. | 2011-12-01 | 126 | 0 |
| K110741 | SCEPTER C OCCLUSION BALLOON CATHETER | MicroVention, Inc. | 2011-09-29 | 197 | 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