510(k) K060673 ยท FAD Stent, Ureteral
PEDIATRIC URETERAL STENT
| Applicant | Applied Medical Resources Corp., Rancho Santa CA, US |
| Decision | Substantially Equivalent, Mar 29, 2006 |
| Received | Mar 14, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K060673
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 16, 2008 | Applied Medical Resources Corp SILHOUETTE XTRAFLO DEVICE WITH SL-6 HYDROPHILIC COATING, MODEL NUMBER: B3856, SIZE 6F x 24cm Urological stents are disposable single-use temporary indwelling catheters that allow urine to drain thro Terminated |
FAD | None listed |
| Sep 16, 2008 | Applied Medical Resources Corp SILHOUETTE XTRAFLO DEVICE WITH SL-6 HYDROPHILIC COATING, MODEL NUMBER: B3857, SIZE 6F x 26cm Urological stents are disposable single-use temporary indwelling catheters that allow urine to drain th Terminated |
FAD | None listed |
| Sep 16, 2008 | Applied Medical Resources Corp SILHOUETTE XTRAFLO DEVICE WITH SL-6 HYDROPHILIC COATING, MODEL NUMBER: B3855, SIZE 6F x 22cm Urological stents are disposable single-use temporary indwelling catheters that allow urine to drain thro Terminated |
FAD | None listed |
| Sep 16, 2008 | Applied Medical Resources Corp SILHOUETTE XTRAFLO DEVICE WITH SL-6 HYDROPHILIC COATING, MODEL NUMBER: B3827, SIZE 6F multilength Urological stents are disposable single-use temporary indwelling catheters that allow urine to dra Terminated |
FAD | None listed |
| Sep 16, 2008 | Applied Medical Resources Corp SILHOUETTE XTRAFLO DEVICE WITH SL-6 HYDROPHILIC COATING, MODEL NUMBER: BS123, SIZE 6F multilength
Urological stents are disposable sing-use temporary indwelling catheters that allow urine to drain th Terminated |
FAD | None listed |
| Sep 16, 2008 | Applied Medical Resources Corp SILHOUETTE XTRAFLO DEVICE WITH SL-6 HYDROPHILIC COATING, MODEL NUMBER: B3957, SIZE 6F x 26cm
Urological stents are disposable single-use temporary indwelling catheters that allow urine to drain throug Terminated |
FAD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.