510(k) K093257 ยท OFC Catheter Introducer Kit
TORQMAX SHEATH GRIP ACCESSORY
| Applicant | Spectranetics Corp., Colorado Springs CO, US |
| Decision | Substantially Equivalent, Mar 26, 2010 |
| Received | Oct 19, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K093257
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.