510(k) K970159 ยท FJS Catheter, Peritoneal, Long-Term Indwelling
FLEX-NECK PD CATHETER
| Applicant | Janin Group, Inc., Aurora IL, US |
| Decision | Substantially Equivalent, Sep 5, 1997 |
| Received | Jan 16, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970159
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 20, 2017 | Merit Medical Systems, Inc. Flex-Neck Classic Peritoneal Dialysis Catheter (Pediatric)
Product Usage:
If the patient is a suitable candidate for peritoneal dialysis (PD) therapy, The Flex-Neck PD Catheter can be implanted eithe Terminated |
FJS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.