510(k) K052185 ยท DYB Introducer, Catheter
DESTINATION CAROTID GUIDING SHEATH
| Applicant | Terumo Medical Corp., Elkton MD, US |
| Decision | Substantially Equivalent, Sep 6, 2005 |
| Received | Aug 11, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K052185
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 6, 2011 | Terumo Medical Corporation Pinnacle Destination Guiding Sheath, 7 French, 90 cm, Straight Tip, Tuohy-Borst Valve, Lots ME07 & MF12, 510(k) K052185
Guiding Sheath is used to facilitate the introduction of interventional and dia Terminated |
DYB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.