510(k) K952828 ยท DYB Introducer, Catheter
MEDI-TECH PERCUTANEOUS INTRODUCER SYSTEM
| Applicant | Boston Scientific Corp, Natick, MA, US |
| Decision | Substantially Equivalent, Aug 18, 1995 |
| Received | Jun 20, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K952828
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 7, 2007 | Boston Scientific Corp Boston Scientific ACCUSTICK II Introducer System with .038 inch Stainless Steel J Tip and .018 inch Nitinol Guidewire, sterile, REF/Catalog No. 20-710; UPN/Material Number: M001207100, Boston Scientif Terminated |
DYB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.