510(k) K953951 ยท GCA Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
WILSON-COOK TRIPLE LUMEN BALLOON STONE EXTRACTOR
| Applicant | Wilson-Cook Medical, Inc., Winston-Salem NC, US |
| Decision | Substantially Equivalent, Sep 19, 1995 |
| Received | Aug 22, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K953951
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 24, 2003 | Wilson-Cook Medical Inc Howell D.A.S.H. Extraction Balloon, DASH-8.5-12-15, with Multiple Sizing, Catheter: 6 FR./200 CM. , Shelf Life: 1 Year, Sterile, Disposable, Single Use Only, Wilson-Cook Medical, 4900 Bethania Station Terminated |
GCA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.