510(k) K024050 ยท LJE Catheter, Nephrostomy
COOK NEPHROSTOMY DILATION BALLOON CATHETER SET
| Applicant | Cook Urological, Inc., Spencer IN, US |
| Decision | Substantially Equivalent, Feb 27, 2003 |
| Received | Dec 9, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K024050
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 24, 2016 | Cook Inc. UltraxxTM Nephrostomy Balloon Set
The Ultraxx" Nephrostomy Balloon Set consists of a radiopaque balloon catheter, radiopaque sheath, and inflation device. The Ultraxx" Nephrostomy Balloon Set is used Terminated |
LJE | None listed |
| Mar 24, 2016 | Cook Inc. Ascend AQ Ureteral Dilation Balloon Catheter Set
The Ascend AQ Ureteral Dilation Balloon Catheter Set consists of a radiopaque balloon catheter and inflation device. The Ascend AQ Ureteral Dilation Ba Terminated |
LJE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.