Scimed Peripheral Interventions: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Scimed Peripheral Interventions” (first 1993, latest 1995), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 103 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 | 4 | 4 |
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | 2 | 2 |
| DQY | Catheter, Percutaneous | 1 | 1 |
| KRA | Catheter, Continuous Flush | 1 | 1 |
Review panels
- Cardiovascular (8)
Most recent Scimed Peripheral Interventions 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K945904 | SCIMED(R) VENTURE(TM) II INFUSION CATHETER | KRA | 1995-05-19 | 168 |
| K946272 | SCIMED(R) COURIER GUIDE CATHETER | DQY | 1995-04-17 | 115 |
| K944677 | SCIMED TRANSENT EX STEERABLE GUIDE WIRE AND ACCESSORIES | DQX | 1995-02-08 | 139 |
| K941710 | SCIMED TRANSEND STEERABLE GUIDE WIRE AND ACCESSORIES | DQX | 1994-09-01 | 148 |
| K935501 | SCIMED VIPER PTA CATHETER WITH BIOSLIDE HYDROPHILIC COATING | LIT | 1994-01-27 | 72 |
| K934793 | SCIMED MAVERICK | LIT | 1994-01-05 | 91 |
| K934359 | SCIMED STRIKE STEERABLE GUIDE WIRE | DQX | 1993-10-07 | 29 |
| K934122 | SCIMED TRANSEND EX STEERABLE GUIDE WIRE AND ACCESSORIES | DQX | 1993-10-07 | 43 |
Recalls
openFDA lists no recalls under a recalling firm named Scimed Peripheral Interventions.
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 (8 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Scimed Peripheral Interventions?
FDA lists 8 510(k) clearances under the applicant name “Scimed Peripheral Interventions” (first 1993, latest 1995), across 4 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 Peripheral Interventions?
The median time from FDA receipt to decision across 510(k)s cleared under the name Scimed Peripheral Interventions is 103 days.
Which FDA product codes appear under Scimed Peripheral Interventions?
The most frequent FDA product codes under this applicant name are DQX (Wire, Guide, Catheter, 4); LIT (Catheter, Angioplasty, Peripheral, Transluminal, 2); DQY (Catheter, Percutaneous, 1).
Next steps
- See all 8 Scimed Peripheral Interventions clearances with predicates and recalls
- Run predicate analysis for product code DQX, Scimed Peripheral Interventions'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.