510(k) K963397 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
ULTRA-THIN DIAMOND BALLOON DILATATION CATHETER
| Applicant | Boston Scientific Corp, Natick, MA, US |
| Decision | Substantially Equivalent, Nov 25, 1996 |
| Received | Aug 29, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963397
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 25, 2010 | Boston Scientific Corporation Boston Scientific, Ultra-thin" Diamond" Balloon Dilatation Catheters, M001164040 (DT/3-4/5/40, 16-404), M001164360 (DT/5-2/5/40, 16-436),M001164620 (DT/6-4/5/40, 16-462), Made in Ireland, Ballybrit Terminated |
FGE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.