510(k) K941851 ยท KOC Accessories, Blood Circuit, Hemodialysis
DUAL LUMEN CATHETER (DLC) TRAY
| Applicant | Neostar Medical Technologies, Inc., New Brunswick NJ, US |
| Decision | Substantially Equivalent, Mar 13, 1995 |
| Received | Apr 14, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K941851
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2004 | Horizon Medical Products Inc Circle C Dual Lumen Acute Hemodialysis/Apheresis Catheter Surgical Tray, DLC-600TEC, 12 Fr. x 15.2cm, Sterile, Manufactured by: Horizon Medical Products, Inc., One Horizon Way, P.O. Box 627, Manchest Terminated |
KOC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.