510(k) K091329 ยท DYB Introducer, Catheter
PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH
| Applicant | Terumo Medical Corp., Elkton MD, US |
| Decision | Substantially Equivalent, May 29, 2009 |
| Received | May 5, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K091329
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 27, 2013 | Terumo Medical Corporation Pinnacle Destination Peripheral Guiding Sheath, 8 French, 90cm, Straight Tip, Cross Cut Valve.
Acts as a conduit to facilitate the introduction of interventional and diagnostic devices into the human Terminated |
DYB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.