510(k) K042065 ยท MQR Stent, Colonic, Metallic, Expandable
WALLFLEX ENTERNAL COLONIC STENT AND ANCHOR LOCK DELIVERY SYSTEM
| Applicant | Boston Scientific Corp, Natick, MA, US |
| Decision | Substantially Equivalent, Sep 30, 2004 |
| Received | Aug 2, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042065
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 7, 2018 | SPS Sterilization, Inc Boston Scientific Wallstent Enteral Endoprosthesis Colonic/Duodenal Stent, 22MM X 90MM, resterilized. Terminated |
MQR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.