MicroVention, Inc.: FDA filings under this applicant name
FDA lists 86 510(k) clearances under the applicant name “MicroVention, Inc.” (first 2001, latest 2025), plus 4 PMA decisions, across 16 product codes in 4 review panels. Median 510(k) review time under this name: 91 days. Since 2017 the median was 204 days, against 118 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Terumo, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 8 | 29 |
| 2013 | 7 | 99 |
| 2014 | 2 | 158 |
| 2015 | 6 | 144 |
| 2016 | 5 | 92 |
| 2017 | 2 | 164 |
| 2018 | 2 | 264 |
| 2019 | 3 | 236 |
| 2020 | 5 | 118 |
| 2021 | 0 | — |
| 2022 | 3 | 264 |
| 2023 | 3 | 177 |
| 2024 | 1 | 268 |
| 2025 | 1 | 200 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name MicroVention, Inc. took a median 204 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 118 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HCG | Device, Neurovascular Embolization | 32 | 32 |
| KRD | Device, Vascular, For Promoting Embolization | 18 | 18 |
| DQY | Catheter, Percutaneous | 16 | 16 |
| MOF | Guide, Wire, Catheter, Neurovasculature | 6 | 6 |
| DQX | Wire, Guide, Catheter | 3 | 3 |
| MJN | Catheter, Intravascular Occluding, Temporary | 3 | 3 |
| NRY | Catheter, Thrombus Retriever | 2 | 2 |
| QJP | Catheter, Percutaneous, Neurovasculature | 2 | 2 |
| DQO | Catheter, Intravascular, Diagnostic | 1 | 1 |
| JCX | Apparatus, Suction, Ward Use, Portable, Ac-Powered | 1 | 1 |
Plus 6 more product codes.
Review panels
Most recent MicroVention, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K243638 | MV Flow Aspiration Pump (MVFLOWPMP01) | JCX | 2025-06-13 | 200 |
| K232542 | Wedge XL Delivery Catheter | QJP | 2024-05-16 | 268 |
| K230775 | SOFIA EX Intracranial Support Catheter | QJP | 2023-09-14 | 177 |
| K222694 | EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190) | NTE | 2023-04-27 | 233 |
| K222115 | ISAAC Neurovascular Navigation Catheter | DQY | 2023-01-10 | 176 |
| K223050 | AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035; 45-880050; 45-880060) | KRD | 2022-12-21 | 83 |
| K214024 | SOFIA 88 Catheter | DQY | 2022-09-12 | 264 |
| K211120 | ERIC Retrieval Device | NRY | 2022-03-31 | 350 |
| K193607 | BOBBY Balloon Guide Catheter | DQY | 2020-07-21 | 208 |
| K201487 | Traxcess 7 Mini Guidewire | MOF | 2020-07-02 | 28 |
76 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P210030 | PMA | Roadsaver/CASPER Carotid Stent Device | 2024-11-20 |
| P180027 | PMA | Flow Re-Direction Endoluminal Device (FRED®) System | 2019-12-16 |
| P170032 | PMA | Woven EndoBridge (WEB) Aneurysm Embolization System | 2018-12-31 |
| P170013 | PMA | Low-Profile Visualized Intraluminal Support (LVIS) and LVIS Jr. | 2018-05-30 |
Recalls
38 product recalls in 16 recall events; 12 initiated in the last five years. Most recent: 2026-04-30.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- MicroVention, Inc., d/b/a Terumo Neuro (3 510(k)s)
- MicroVention, Inc. A TERUMO Group Company (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under MicroVention, Inc.?
FDA lists 86 510(k) clearances under the applicant name “MicroVention, Inc.” (first 2001, latest 2025), plus 4 PMA decisions, across 16 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by MicroVention, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name MicroVention, Inc. is 91 days. Since 2017: 204 days, versus 118 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under MicroVention, Inc.?
The most frequent FDA product codes under this applicant name are HCG (Device, Neurovascular Embolization, 32); KRD (Device, Vascular, For Promoting Embolization, 18); DQY (Catheter, Percutaneous, 16).
Next steps
- See all 86 MicroVention, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HCG, MicroVention, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.