Microvena Corp.: FDA filings under this applicant name
FDA lists 18 510(k) clearances under the applicant name “Microvena Corp.” (first 1990, latest 1999), across 6 product codes in 1 review panel. Median 510(k) review time under this name: 173 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DQX | Wire, Guide, Catheter | 8 | 8 |
| DQY | Catheter, Percutaneous | 3 | 3 |
| MCW | Catheter, Peripheral, Atherectomy | 3 | 3 |
| DXE | Catheter, Embolectomy | 2 | 2 |
| DRE | Dilator, Vessel, For Percutaneous Catheterization | 1 | 1 |
| DYB | Introducer, Catheter | 1 | 1 |
Review panels
- Cardiovascular (18)
Most recent Microvena Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K991898 | ULTRA-SELECT GUIDEWIRE, HYTEK GUIDEWIRE | DQX | 1999-06-16 | 12 |
| K991194 | MODIFICATION TO ULTRA-SELECT GUIDEWIRE | DQX | 1999-05-05 | 27 |
| K982657 | AMPLATZ THROMBECTOMY DEVICE MODELS ATD 601, ATD 602, ATD 801, ATD 802, FOOT PEDAL ASSEMBLY MODEL AK 100 | MCW | 1998-11-18 | 111 |
| K970668 | THE AMPLANTZ GOOSE NECK MICROSNARE | DQY | 1998-06-10 | 471 |
| K972511 | AMPLATZ GOOSE NECK SNARE KIT/ CATHETER | DXE | 1998-03-06 | 246 |
| K971984 | AMPLATZ THROMBECTOMY DEVICE(ATD 603,602,801,802)/FOOT PEDAL ASSEMBLY(AK 200) | MCW | 1997-09-19 | 113 |
| K954642 | HYDRO-SELECT GUIDEWIRE | DQX | 1996-12-17 | 434 |
| K954205 | THE AMPLATZ THROMBECTOMY DEVICE | MCW | 1996-08-13 | 341 |
| K955304 | CRICKET | DQX | 1996-05-16 | 178 |
| K952860 | THE NINER NITINOL GUIDEWIRE | DQX | 1995-12-13 | 174 |
8 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Microvena Corp..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Microvena Corp.?
FDA lists 18 510(k) clearances under the applicant name “Microvena Corp.” (first 1990, latest 1999), across 6 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Microvena Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Microvena Corp. is 173 days.
Which FDA product codes appear under Microvena Corp.?
The most frequent FDA product codes under this applicant name are DQX (Wire, Guide, Catheter, 8); DQY (Catheter, Percutaneous, 3); MCW (Catheter, Peripheral, Atherectomy, 3).
Next steps
- See all 18 Microvena Corp. clearances with predicates and recalls
- Run predicate analysis for product code DQX, Microvena Corp.'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.