510(k) K110653 ยท EZD Catheter, Straight
CURE CATHETER
| Applicant | Cure Medical, LLC, Irvine CA, US |
| Decision | Substantially Equivalent, Aug 1, 2011 |
| Received | Mar 7, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K110653
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 16, 2014 | Cure Medical LLC Pediatric, 10Fr, Intermittent Urinary Catheters
Model: P10
Pouch Label UPC (P10) *+M405P100C*
Intermediate Box Label UPC (P10) *+M405P103F*
Carton Label UPC (P10) *+M405P105H*
The product is distribu Terminated |
EZD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.