510(k) K031351 ยท FJS Catheter, Peritoneal, Long-Term Indwelling
FLEX-NECK PD CATHETER, INFANT
| Applicant | Medigroup, Inc., Naperville IL, US |
| Decision | Substantially Equivalent, Sep 17, 2003 |
| Received | Apr 29, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K031351
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 20, 2017 | Merit Medical Systems, Inc. Flex-Neck Classic Peritoneal Dialysis Catheter 1 Cuff Infant Coiled, Catalog # CF-4235/B Terminated |
FJS | None listed |
| Sep 20, 2017 | Merit Medical Systems, Inc. Custom Dialysis Kit CF-4235 Without Gel, which includes Flex-Neck Classic Peritoneal Dialysis Catheter 1 Cuff Infant Coiled, Catalog # K14-00079 Terminated |
OJV | None listed |
| Sep 20, 2017 | Merit Medical Systems, Inc. Custom Dialysis Kit CF-4230 Without Gel, which includes Flex-Neck Classic Peritoneal Dialysis Catheter 2 Cuffs Infant Coiled, Catalog # K14-00078 Terminated |
OJV | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.