510(k) K060323 ยท MQR Stent, Colonic, Metallic, Expandable
ULTRAFLEX PRECISION COLONIC STENT, MODELS M00557330, MO00557360, M00557380
| Applicant | Boston Scientific Corporation, Marlboro MA, US |
| Decision | Substantially Equivalent, May 12, 2006 |
| Received | Feb 9, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K060323
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 31, 2010 | Boston Scientific Corporation Boston Scientific Ultraflex Precision Colonic Stent System
Material/UPN/Catalog Number: M00557360 Terminated |
MQR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.