510(k) K945379 ยท DQX Wire, Guide, Catheter
PLATINUM PLUS GUIDEWIRE WITH HYDROPHILIC COATING
| Applicant | Boston Scientific Corp, Watertown MA, US |
| Decision | Substantially Equivalent, Jun 5, 1995 |
| Received | Nov 2, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K945379
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 2, 2008 | Boston Scientific Corporation Platinum Plus" LT , REF 46-601, UPN M001466010, LT/0.018/180, Sterilized with ethylene oxide gas, Rx only, Legal Manufacturer Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01 Terminated |
DQX | None listed |
| Oct 2, 2008 | Boston Scientific Corporation Platinum Plus" LT , REF 46-602, UPN M001466020, LT/0.018/260, Sterilized with ethylene oxide gas, Rx only, Legal Manufacturer Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01 Terminated |
DQX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.