510(k) K072539 ยท EZD Catheter, Straight
CURE CATHETER
| Applicant | Cure Medical, LLC, Laguna Niguel CA, US |
| Decision | Substantially Equivalent, Sep 13, 2007 |
| Received | Sep 10, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K072539
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 2, 2012 | Cure Medical LLC Male, 16Fr, Straight-tip Intermittent Urinary Catheters M16. The product is distributed individually or in intermediate boxes containing 30 individual, sterile packaged catheters (PA/PE film and dialy Terminated |
EZD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.