510(k) K901815 ยท DRE Dilator, Vessel, For Percutaneous Catheterization
MODIFIED STERILIZATION OF INTRA-ART(TM) CORONARY
| Applicant | Pioneering Technologies, Inc., Wheat Ridge CO, US |
| Decision | Substantially Equivalent, Jul 3, 1990 |
| Received | Apr 23, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K901815
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.