510(k) K163314 ยท DQY Catheter, Percutaneous
Guidezilla II Guide Extension Catheter; Guidezilla II LONG Guide Extension Catheter
| Applicant | Boston Scientific Corporation, Maple Grove MN, US |
| Decision | Substantially Equivalent, Mar 23, 2017 |
| Received | Nov 23, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163314
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 24, 2019 | Boston Scientific Corporation Guidezilla II Guide Extension Catheter Sterilized using ethylene oxide. Packaged in the following sizes:
1. REF/Catalog No. H7493933515060, 6F;
2. REF/Catalog No H7493933515070, 7F. Terminated |
DQY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.