510(k) K935457 ยท GDF Guide, Needle, Surgical
LOCALIZATION WIRE OR MARKER - SURGICAL
| Applicant | Bip USA, Inc., Niagara Falls NY, US |
| Decision | Substantially Equivalent, Feb 17, 1994 |
| Received | Nov 12, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K935457
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 16, 2014 | Bard Peripheral Vascular Inc Bard DuaLok Breast Lesion Localization Wire,
Product Code (Gauge x Length) LW0037 (20gx37mm); LW0057 (20gx57mm), LW0077(20gx77mm), LW0107(20gx107mm), LW0137(20gx137mm).
The Bard DuaLok Breast Lesion Terminated |
GDF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.