510(k) K012812 ยท DYB Introducer, Catheter
CAROTID GUIDING SHEATH
| Applicant | Terumo Medical Corp., Elkton MD, US |
| Decision | Substantially Equivalent, Nov 14, 2001 |
| Received | Aug 22, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012812
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 6, 2011 | Terumo Medical Corporation Pinnacle Destination Guiding Sheath, 6 French, 90 cm, Straight Tip, Tuohy-Borst Valve, Lot MD24, MD31, ME07, & ME14. 510(k) K012812
Guiding Sheath is used to facilitate the introduction of interven Terminated |
DYB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.