510(k) K043254 ยท EZN Dilator, Catheter, Ureteral
PATHWAY URETERAL ACCESS SHEATH, PATHWAY EXPANDABLE URETERAL ACCESS SHEATH
| Applicant | Onset Medical Corporation, Mission Viejo CA, US |
| Decision | Substantially Equivalent, Feb 10, 2005 |
| Received | Nov 24, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K043254
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.