510(k) K864705 ยท DYB Introducer, Catheter
MODIFICATION (MATERIAL CHANGE) OF PEEL-AWAY SHEATH
| Applicant | Quinton, Inc., Seattle WA, US |
| Decision | Substantially Equivalent, Feb 13, 1987 |
| Received | Dec 2, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K864705
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.