Boston Scientific Scimed, Inc.: FDA filings under this applicant name
FDA lists 35 510(k) clearances under the applicant name “Boston Scientific Scimed, Inc.” (first 1994, latest 2004), plus 5 PMA decisions, across 13 product codes in 3 review panels. Median 510(k) review time under this name: 86 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 |
|---|---|---|---|
| JCT | Prosthesis, Tracheal, Expandable | 9 | 9 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 7 | 7 |
| DQO | Catheter, Intravascular, Diagnostic | 5 | 5 |
| DQY | Catheter, Percutaneous | 5 | 5 |
| MAF | Stent, Coronary | 4 | 0 |
| ESW | Prosthesis, Esophageal | 2 | 2 |
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | 2 | 2 |
| DQX | Wire, Guide, Catheter | 1 | 1 |
| DYG | Catheter, Flow Directed | 1 | 1 |
| MQR | Stent, Colonic, Metallic, Expandable | 1 | 1 |
Plus 3 more product codes.
Review panels
- Cardiovascular (20)
- Gastroenterology and Urology (11)
- Anesthesiology (9)
Most recent Boston Scientific Scimed, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K041727 | MODIFICATION TO ATLANTIS PV IMAGING CATHETER, MODEL 36456 | OBJ | 2004-07-23 | 28 |
| K030617 | PT2 GUIDE WIRE AND ADDWIRE EXTENSION WIRE | DQX | 2003-05-21 | 84 |
| K024048 | MODIFICATION TO BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM | FGE | 2003-01-06 | 28 |
| K021735 | BOSTON SCIENTIFIC ULTRA-SOFT SV BALLOON DILATATION CATHETER | DQY | 2002-08-08 | 72 |
| K021901 | WALLGRAFT TRACHEOBRONCHIAL ENDOPROTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM | JCT | 2002-07-09 | 29 |
| K012822 | MODIFICIATION TO: BILIARY WALLSTENT ENDOPROSTHEIS WITH MONORAIL DELIVERY SYSTEM, MODEL 71-XXX | FGE | 2001-10-24 | 62 |
| K012216 | NIROYAL BILIARY PREMOUNTED STENT SYSTEM | FGE | 2001-08-17 | 32 |
| K000743 | BOSTON SCIENTIFIC SCIMED ATLANTIS CORONARY IMAGING CATHETER, MODEL C4020 | DQO | 2000-09-06 | 183 |
| K000001 | WALLGRAFT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP DELIVERY SYSTEM | JCT | 2000-06-05 | 154 |
| K000956 | MODIFICATION TO SCIMED 6F IMPULSE ANGIOGRAPHIC CATHATERS | DQO | 2000-04-21 | 28 |
25 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P040016 | PMA | VERIFLEX (LIBERTE) BARE-METAL CORONARY STENT SYSTEM | 2005-04-12 |
| P020009 | PMA | EXPRESS/EXPRESS 2 MR & OTW CORONARY STENT SYSTEMS | 2002-09-11 |
| P980009 | PMA | MAGIC WALLSTENT ENDOPROTHESIS | 1998-09-29 |
| P970061 | PMA | SCIMED RADIUS CORONARY STENT WITH DELIVERY SYSTEM | 1998-07-16 |
| P940019 | PMA | WALLSTENT(R) ILIAC ENDOPROSTHESIS | 1996-05-28 |
Recalls
44 product recalls in 14 recall events; 0 initiated in the last five years. Most recent: 2005-08-05.
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 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 /International Technologies (5 510(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 Scimed, Inc.?
FDA lists 35 510(k) clearances under the applicant name “Boston Scientific Scimed, Inc.” (first 1994, latest 2004), plus 5 PMA decisions, across 13 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 Boston Scientific Scimed, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Boston Scientific Scimed, Inc. is 86 days.
Which FDA product codes appear under Boston Scientific Scimed, Inc.?
The most frequent FDA product codes under this applicant name are JCT (Prosthesis, Tracheal, Expandable, 9); FGE (Stents, Drains And Dilators For The Biliary Ducts, 7); DQO (Catheter, Intravascular, Diagnostic, 5).
Next steps
- See all 35 Boston Scientific Scimed, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JCT, Boston Scientific Scimed, 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.