510(k) K034061 ยท DYB Introducer, Catheter
MODIFICATION TO CONVOY ADVANCED DELIVERY SHEATH
| Applicant | Boston Scientific Corp, San Jose CA, US |
| Decision | Substantially Equivalent, Jan 30, 2004 |
| Received | Dec 31, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K034061
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 9, 2009 | Boston Scientific Corp Soft Tip Sheath Multipurpose Introducing Sheath Kit, Model Numbers:
M00456600,
M00456610,
M00456620,
M00456630,
M00456650,
M00456700,
M00456710 and
M00456760.
Manufactured by Thomas Medical Terminated |
DYB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.