510(k) K970466 ยท LIT Catheter, Angioplasty, Peripheral, Transluminal
RADIUS PTCA GUIDEWIRE
| Applicant | Radius Medical Technologies, Inc., Maynard MA, US |
| Decision | Substantially Equivalent, May 20, 1997 |
| Received | Feb 7, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970466
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 15, 2013 | Medtronic Vascular THUNDER Extra Support Guidewire; Models: THNDR190J, THNDR190S, THNDR300J, THNDR300S
Medtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or Terminated |
LIT | None listed |
| Nov 15, 2013 | Medtronic Vascular THUNDER Steerable Guidewire; Model: LVTNDR190S
Medtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or interventional devices in the corona Terminated |
LIT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.