Boston Scientific /International Technologies: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Boston Scientific /International Technologies” (first 1994, latest 1997), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 210 days. 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 Boston Scientific, based on public ownership records.
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 | 3 | 3 |
| DQY | Catheter, Percutaneous | 1 | 1 |
| DYB | Introducer, Catheter | 1 | 1 |
Review panels
- Cardiovascular (5)
Most recent Boston Scientific /International Technologies 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K971688 | IVT 0.014 PTFE-COATED TRACKWIRE | DQX | 1997-12-11 | 218 |
| K963663 | 11F GUIDING CATHETER | DQY | 1997-01-13 | 122 |
| K954622 | IVT 0.014 TRACK OR IVT 0.014 ACCUTRACK | DQX | 1996-04-29 | 207 |
| K954552 | RAILWIRE | DQX | 1996-04-29 | 210 |
| K930808 | PROTECTOR INTRODUCER SHEATH | DYB | 1994-03-15 | 392 |
Recalls
openFDA lists no recalls under a recalling firm named Boston Scientific /International Technologies.
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.
- Boston Scientific Corp (730 510(k)s)
- Boston Scientific Scimed, Inc. (35 510(k)s)
- Boston Medical Products, Inc. (33 510(k)s)
- Boston Scientific, Target (19 510(k)s)
- Boston Surgical Products, Inc. (17 510(k)s)
- Boston Biomedica, Inc. (12 510(k)s)
- Boston Pacific Medical, Inc. (11 510(k)s)
- Boston Scientific Neuromodulation (10 510(k)s)
- Boston Medical Corp. (8 510(k)s)
- Boston Aesthetics, Inc. (6 510(k)s)
- Boston Scientific/Medi-Tech (5 510(k)s)
- Boston Brace Intl., Inc. (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Boston Scientific /International Technologies?
FDA lists 5 510(k) clearances under the applicant name “Boston Scientific /International Technologies” (first 1994, latest 1997), across 3 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 Boston Scientific /International Technologies?
The median time from FDA receipt to decision across 510(k)s cleared under the name Boston Scientific /International Technologies is 210 days.
Which FDA product codes appear under Boston Scientific /International Technologies?
The most frequent FDA product codes under this applicant name are DQX (Wire, Guide, Catheter, 3); DQY (Catheter, Percutaneous, 1); DYB (Introducer, Catheter, 1).
Next steps
- See all 5 Boston Scientific /International Technologies clearances with predicates and recalls
- Run predicate analysis for product code DQX, Boston Scientific /International Technologies'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.