510(k) K954302 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
VYGON PREMI-CATH - LONG TERM CATHETER
| Applicant | Vygon Corp., Elizabeth NJ, US |
| Decision | Substantially Equivalent, Jun 17, 1996 |
| Received | Sep 13, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K954302
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 24, 2017 | Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. CVC Tray Pediatrics. Product Code: AMS-9335CP-2. Terminated |
LJS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.