510(k) K011664 ยท DQO Catheter, Intravascular, Diagnostic
IMAGER II ANGIOGRAPHIC CATHETER
| Applicant | Boston Scientific/Medi-Tech, Natick, MA, US |
| Decision | Substantially Equivalent, Sep 7, 2001 |
| Received | May 30, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K011664
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 11, 2012 | Boston Scientific Corporation Boston Scientific, IMAGER II Angiographic Catheter, Sterilized with ethylene oxide gas. Made in Ireland, Manufactured for Boston Scientific Corporation, One Boston Scientific Place, Natick, MA 01760-1 Terminated |
DQO | None listed |
| Dec 6, 2007 | Boston Scientific Corporation Boston Scientific, Imager II Angiographic Catheter, (Outer Carton Label): UPN M001315081, 5 Fr, 100 cm, Catalog No. 31-508, Lot 48951, Description 5 Fr Flush TR, Sterile EO, Made in Ireland, Unit 7, Terminated |
DQO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.