510(k) K102008 ยท DYB Introducer, Catheter
GLIDESHEATH
| Applicant | Terumo Medical Corp., Elkton MD, US |
| Decision | Substantially Equivalent, Jul 21, 2010 |
| Received | Jul 16, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K102008
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 27, 2013 | Terumo Medical Corporation Terumo Glidesheath (tm), 6 French, Nitinol wire, product code 15-1060.
Used to facilitate placing a catheter through the skin into a vein or artery. Terminated |
DYB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.