Boston Scientific/Medi-Tech: FDA clearances and approvals
Boston Scientific/Medi-Tech has 5 FDA 510(k) clearances (first 2001, latest 2002), across 4 product codes in 2 review panels. Median 510(k) review time: 29 days.
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 |
|---|---|---|---|
| DQO | Catheter, Intravascular, Diagnostic | 2 | 2 |
| DSY | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter | 1 | 1 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 1 | 1 |
| MSD | Catheter, Hemodialysis, Implanted | 1 | 1 |
Review panels
Most recent Boston Scientific/Medi-Tech 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K023870 | FLEXIMA BILIARY CATHETER | FGE | 2002-12-20 | 30 |
| K020012 | MODIFICATION TO RENEGADE FIBER BRAIDED MICROCATHETER | DQO | 2002-01-29 | 26 |
| K012948 | MODIFICATION TO VAXCEL DIALYSIS CATHETER | MSD | 2001-10-03 | 29 |
| K012952 | HEMASHIELD GOLD WOVEN DOUBLE VELOUR VASCULAR GRAFT - BRANCH GRAFT | DSY | 2001-10-02 | 28 |
| K011664 | IMAGER II ANGIOGRAPHIC CATHETER | DQO | 2001-09-07 | 100 |
Recalls
openFDA lists no recalls under a recalling firm named Boston Scientific/Medi-Tech.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Boston Scientific/Medi-Tech have?
Boston Scientific/Medi-Tech has 5 FDA 510(k) clearances (first 2001, latest 2002), across 4 product codes in 2 review panels.
How long does FDA take to clear Boston Scientific/Medi-Tech's 510(k)s?
The median time from FDA receipt to decision across Boston Scientific/Medi-Tech's cleared 510(k)s is 29 days.
What devices does Boston Scientific/Medi-Tech make?
Its most frequent FDA product codes are DQO (Catheter, Intravascular, Diagnostic, 2); DSY (Prosthesis, Vascular Graft, Of 6mm And Greater Diameter, 1); FGE (Stents, Drains And Dilators For The Biliary Ducts, 1).
Has Boston Scientific/Medi-Tech had device recalls?
openFDA lists no recalls under a recalling firm name matching Boston Scientific/Medi-Tech. Related entities may recall under other names.
Next steps
- See all 5 Boston Scientific/Medi-Tech clearances with predicates and recalls
- Run predicate analysis for product code DQO, Boston Scientific/Medi-Tech's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.