Scimed: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Scimed” (first 1990, latest 1999), across 6 product codes in 1 review panel. Median 510(k) review time under this name: 85 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 |
|---|---|---|---|
| DQO | Catheter, Intravascular, Diagnostic | 2 | 2 |
| DQX | Wire, Guide, Catheter | 2 | 2 |
| DQY | Catheter, Percutaneous | 1 | 1 |
| DTR | Heat-Exchanger, Cardiopulmonary Bypass | 1 | 1 |
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | 1 | 1 |
| MAV | Syringe, Balloon Inflation | 1 | 1 |
Review panels
- Cardiovascular (8)
Most recent Scimed 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K992142 | SCIMED ANGIOGRAPHIC CATHETERS | DQO | 1999-07-21 | 27 |
| K953909 | SCIMED 6 FRENCH MICRO-MAX GUIDE CATHETER | DQY | 1995-11-13 | 84 |
| K931584 | SCIMED TRANSPORT STEERABLE GUIDE WIRE AND ACCESS. | DQX | 1993-07-01 | 92 |
| K922706 | SCIMED SIDELINER | DQX | 1992-12-10 | 188 |
| K915347 | SCIMED VIPER CATHETER | LIT | 1992-08-17 | 265 |
| K910987 | 7FR. AND 8FR. TRIGUIDE GUIDING CATHETER ADD. CURVE | DQO | 1991-05-29 | 83 |
| K904171 | SCIMED CARDIOTHERM CARDIOPLEGIA DELIVERY SYSTEM | DTR | 1990-12-06 | 86 |
| K903503 | SCIMED ENCORE INFLATION DEVICE, MODEL SM2500 | MAV | 1990-10-09 | 67 |
Recalls
openFDA lists no recalls under a recalling firm named Scimed.
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.
- Scimed Life Systems, Inc. (109 510(k)s)
- Scimed Peripheral Interventions (8 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Scimed?
FDA lists 8 510(k) clearances under the applicant name “Scimed” (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 Scimed?
The median time from FDA receipt to decision across 510(k)s cleared under the name Scimed is 85 days.
Which FDA product codes appear under Scimed?
The most frequent FDA product codes under this applicant name are DQO (Catheter, Intravascular, Diagnostic, 2); DQX (Wire, Guide, Catheter, 2); DQY (Catheter, Percutaneous, 1).
Next steps
- See all 8 Scimed clearances with predicates and recalls
- Run predicate analysis for product code DQO, Scimed'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.