510(k) K071049 ยท EZL Catheter, Retention Type, Balloon
DOVER 100% SILICONE FOLEY CATHETER WITH TEMPERATURE SENSOR
| Applicant | Tyco Healthcare, Mansfield MA, US |
| Decision | Substantially Equivalent, Oct 16, 2007 |
| Received | Apr 13, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K071049
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.