510(k) K954112 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
VYGON LIFEVAC MID-LINE TRAY
| Applicant | Vygon Corp., Elizabeth NJ, US |
| Decision | Substantially Equivalent, May 9, 1996 |
| Received | Jul 31, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K954112
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 20, 2003 | Vygon Corporation Nutriline with Peelable Sheath 2 Fr. is a 2 Fr. peripherally inserted catheter (PIC). Included with this catheter is a 2 Fr. insertion sheath. Product is packaged in tyvek sealed plastic tray. Ster Terminated |
DQO | None listed |
| May 20, 2003 | Vygon Corporation Neonatal Catheter & Insertion Tray is simply a catheter kit that is comprised of the Nutriline Peelable Sheath 2 Fr. catheter and a separately packaged catheter tray. The catheter tray and its respec Terminated |
DQO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.