510(k) K935997 ยท DQX Wire, Guide, Catheter
PLATINUM PLUS GUIDEWIRE
| Applicant | Boston Scientific Corp, Watertown MA, US |
| Decision | Substantially Equivalent, Jun 17, 1994 |
| Received | Dec 15, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K935997
| 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 |
| Sep 21, 2008 | Boston Scientific Corporation Boston Scientific Platinum Plus Guidewire. Material No. [outer carton label] H74917511, Catalog # 1751, Material No. [Inner Pouch Label] H74917510. Sterilized with ethylene oxide gas. The Platinum Terminated |
DQX | None listed |
| Sep 21, 2008 | Boston Scientific Corporation Boston Scientific Platinum Plus Guidewire. Material No. [outer carton label] H74917521, Catalog # 1752, Material No. [Inner Pouch Label] H74917520. Sterilized with ethylene oxide gas. The Platinum Terminated |
DQX | None listed |
| Sep 21, 2008 | Boston Scientific Corporation Boston Scientific Platinum Plus Guidewire. Material No. [outer carton label] H74917531, Catalog # 1753, Material No. [Inner Pouch Label] H74917530. Sterilized with ethylene oxide gas. The Platinum Terminated |
DQX | None listed |
| Sep 21, 2008 | Boston Scientific Corporation Boston Scientific Platinum Plus Guidewire. Material No. [outer carton label] H74917541, Catalog # 1754, Material No. [Inner Pouch Label] H74917540. Sterilized with ethylene oxide gas. The Platinum Terminated |
DQX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.