510(k) K970470 ยท DRE Dilator, Vessel, For Percutaneous Catheterization
EVT EXPANDABLE SHEATH
| Applicant | Guidant Cardiac and Vascular Surgery, Menlo Park CA, US |
| Decision | Substantially Equivalent, Jul 31, 1997 |
| Received | Feb 7, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970470
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.