510(k) K013866 ยท DBY Fab, Rhodamine, Antigen, Antiserum, Control
CONVOY ADVANCED DELIVERY SHEATH KIT
| Applicant | Boston Scientific, San Jose CA, US |
| Decision | Substantially Equivalent, Dec 14, 2001 |
| Received | Nov 21, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K013866
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 9, 2009 | Boston Scientific Corp Convoy Advanced Delivery Sheath Kit, Model Numbers:
M0045660ST0,
M0045661ST0,
M0045662ST0,
M0045663ST0,
M0045665ST0,
M0045667ST0,
M0045670ST0,
M0045672ST0,
M0045675ST0,
M0045676ST0,
M0045690ST0,
M00 Terminated |
DYB | None listed |
| 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.