510(k) K011968 ยท DQX Wire, Guide, Catheter
STREERABLE PTCA GUIDEWIRE
| Applicant | Lake Region Mfg., Inc., Chaska MN, US |
| Decision | Substantially Equivalent, Jul 25, 2001 |
| Received | Jun 25, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K011968
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 24, 2009 | Boston Scientific Corporation Boston Scientific Fort Guide Wire, Floppy Marker Wire, 300cm x 2 cm, REF 34949-02, for use in intravascular interventional procedures. Terminated |
DQX | None listed |
| Jun 24, 2009 | Boston Scientific Corporation Boston Scientific, Fort Guide Wire, Floppy, 300cm x 2 cm REF 34949-04, for use in intravascular interventional procedures. Terminated |
DQX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.