510(k) K052557 ยท DRE Dilator, Vessel, For Percutaneous Catheterization
SUPER SHEATH INTRODUCER SHEATH
| Applicant | Togo Medikit Co., Ltd., Plymouth MN, US |
| Decision | Substantially Equivalent, Jan 17, 2006 |
| Received | Sep 16, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K052557
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 21, 2011 | Boston Scientific Corporation Boston Scientific Super Sheath and Super Sheath R/O Introducer Sheaths, Sterile EO, Manufactured by Togo Medikit Co., Ltd. 17148-6 Aza Kamekawa, Oaza Hichiya, Hyuga City, Miyazaki Prefecture 883-0062 Terminated |
DRE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.