Brivant, Ltd.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Brivant, Ltd.” (first 2008, latest 2012), across 1 product code in 1 review panel. Median 510(k) review time under this name: 69 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 28 |
| 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 | 7 | 7 |
Review panels
- Cardiovascular (7)
Most recent Brivant, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K122856 | CHARTER GUIDEWIRE | DQX | 2012-10-17 | 29 |
| K120137 | VICTORY GUIDEWIRE (32 MODELS) | DQX | 2012-02-14 | 28 |
| K103377 | CHARTER GUIDEWIRE MODEL 45-281, 45-282, 45-283 | DQX | 2011-05-18 | 182 |
| K102211 | CRUISER 18 GUIDEWIRE | DQX | 2010-09-03 | 29 |
| K093515 | 3 PIECE PARODI GUIDEWIRE SYSTEM ( LONG CUT OUTER WITH LONG TAPER .014) SHORT TAPER, 2 PIECE PARODI GUIDEWIRE SYSTEM (LON | DQX | 2010-02-16 | 95 |
| K083094 | STREAMER POLYMER GUIDEWIRE | DQX | 2009-07-07 | 263 |
| K073082 | CPS COURIER GUIDEWIRE | DQX | 2008-01-09 | 69 |
Recalls
openFDA lists no recalls under a recalling firm named Brivant, Ltd..
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.
- Brivant Limited (2 510(k)s)
- Brivant Limited (Lake Region Medical) (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Brivant, Ltd.?
FDA lists 7 510(k) clearances under the applicant name “Brivant, Ltd.” (first 2008, latest 2012), across 1 product code 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 Brivant, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Brivant, Ltd. is 69 days.
Which FDA product codes appear under Brivant, Ltd.?
The most frequent FDA product codes under this applicant name are DQX (Wire, Guide, Catheter, 7).
Next steps
- See all 7 Brivant, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code DQX, Brivant, Ltd.'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.