Vascutech, Inc.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Vascutech, Inc.” (first 1985, latest 2000), across 7 product codes in 3 review panels. Median 510(k) review time under this name: 174 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 |
|---|---|---|---|
| DXE | Catheter, Embolectomy | 4 | 4 |
| MGZ | Valvulotome | 4 | 4 |
| MJN | Catheter, Intravascular Occluding, Temporary | 2 | 2 |
| DWP | Dilator, Vessel, Surgical | 1 | 1 |
| DWS | Instruments, Surgical, Cardiovascular | 1 | 1 |
| KFX | Assembly, Thigh/Knee/Shank/Ankle/Foot, External | 1 | 1 |
| LQR | Dislodger, Stone, Biliary | 1 | 1 |
Review panels
Most recent Vascutech, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K001621 | DARDIK CAROTID SHUNT | MJN | 2000-12-06 | 194 |
| K992942 | LEMAITRE OCCLUSION CATHETER | MJN | 2000-04-13 | 226 |
| K992933 | LEMAITRE IRRIGATION CATHETER | DXE | 2000-03-08 | 190 |
| K992934 | LEMAITRE VENOUS THROMBECTOMY CATHETER | DXE | 2000-03-01 | 183 |
| K992940 | LEMAITRE BALLOON CATHETER WITH IRRIGATION | DXE | 2000-02-22 | 175 |
| K992941 | LEMAITRE BILIARY CATHETER | LQR | 2000-01-12 | 134 |
| K992368 | LEMAITRE EMBOLECTOMY CATHETER | DXE | 1999-12-09 | 147 |
| K980723 | 2.0MM EXPANDABLE LEMAITRE VALVULOTOME (ELV 2.0- GNT) | MGZ | 1999-02-12 | 353 |
| K946352 | LEMAITRE VALVULOTOME II | MGZ | 1995-06-21 | 173 |
| K932009 | THE SAMUELS RETROGRAD VALVULOTOME | MGZ | 1993-09-21 | 151 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Vascutech, Inc..
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.
- VascuTech Medical, LLC (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Vascutech, Inc.?
FDA lists 14 510(k) clearances under the applicant name “Vascutech, Inc.” (first 1985, latest 2000), across 7 product codes in 3 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 Vascutech, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Vascutech, Inc. is 174 days.
Which FDA product codes appear under Vascutech, Inc.?
The most frequent FDA product codes under this applicant name are DXE (Catheter, Embolectomy, 4); MGZ (Valvulotome, 4); MJN (Catheter, Intravascular Occluding, Temporary, 2).
Next steps
- See all 14 Vascutech, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DXE, Vascutech, 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.