510(k) K990072 ยท EZN Dilator, Catheter, Ureteral
BALLOON URETERAL DILATORS, ACCENT DG BALLOON URETERAL DILATOR SET, ASCEND BALLOON DILATION CATHETERS, BALLOON DILATION C
| Applicant | Cook Urological, Inc., Spencer IN, US |
| Decision | Substantially Equivalent, Mar 25, 1999 |
| Received | Jan 11, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K990072
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 13, 2003 | Cook Urological, Inc. Pursuit ureteral dilation balloon catheters, 6 mm x 4 cm. Order # PAB-050080-6-4.0 Terminated |
EZN | None listed |
| Feb 13, 2003 | Cook Urological, Inc. Pursuit ureteral dilation balloon catheters, 6 mm x 8 cm. Order # PAB-050080-6-8.0 Terminated |
EZN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.