510(k) K063695 ยท DQX Wire, Guide, Catheter
RUNTHROUGH NS
| Applicant | Terumo Medical Corp., Elkton MD, US |
| Decision | Substantially Equivalent, Apr 27, 2007 |
| Received | Dec 13, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K063695
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2011 | Terumo Medical Corporation Runthrough NS Tapered PTCA Guidewire, item code number TW*DP418FH
Product Usage The Runthrough NS guidewire is used to facilitate placement of balloon dilation catheters for Percutaneous Translumina Terminated |
DQX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.