510(k) K050630 ยท KRA Catheter, Continuous Flush
PIVOT STEERABLE MICROCATHETER
| Applicant | Boston Scientific - Precision Vascular, West Valley City UT, US |
| Decision | Substantially Equivalent, Mar 22, 2005 |
| Received | Mar 11, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K050630
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 23, 2006 | Boston Scientific Target Boston Scientific brand Pivot Steerable Microcatheter, 1.9F/2.4F,
Catalog #: 1721, Universal Product Number: M00317210,
Product is Manufactured by: Boston Scientific - Precision Vascular, 2405 West Terminated |
KRA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.