510(k) K012854 ยท DYB Introducer, Catheter
RENAL GUIDING SHEATH
| Applicant | Terumo Medical Corp., Elkton MD, US |
| Decision | Substantially Equivalent, Nov 21, 2001 |
| Received | Aug 24, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012854
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 4, 2017 | Terumo Medical Corporation Destination Renal Guiding Sheath
Intended for the introduction of interventional and diagnostic devices into the human vasculature. Terminated |
DYB | None listed |
| Jun 6, 2011 | Terumo Medical Corporation Pinnacle Destination Guiding Sheath, 6 French, 45 cm, Hockey Stick Tip, Tuohy-Borst Valve, Lot ME07, 510 (K) K012854
Guiding Sheath is used to facilitate the introduction of interventional and diagno Terminated |
DYB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.