510(k) K974741 ยท GAA Needle, Aspiration And Injection, Disposable
MANAN ACCURA NEEDLE
| Applicant | Medical Device Technologies, Inc., Gainsville FL, US |
| Decision | Substantially Equivalent, Jan 8, 1998 |
| Received | Dec 19, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974741
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 13, 2010 | Medical Device Technologies, Inc. Angiotech Breast Localization Needles:
A) Accura BLN and Accura II BLN with Stiffening Cannula, STERILE.
Product Numbers: BLN2003, BLN2005, BLN20075, BLN2103, BLN2105, BLN21075, 266050, 266075. 51 Terminated |
GAA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.