510(k) K122649 ยท FED Endoscopic Access Overtube, Gastroenterology-Urology
NAVIGATOR HD URETERAL ACCESS SHEATH SET
| Applicant | Boston Scientific Corp, Marlboro MA, US |
| Decision | Substantially Equivalent, Dec 12, 2012 |
| Received | Aug 30, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K122649
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.