510(k) K003712 ยท KOC Accessories, Blood Circuit, Hemodialysis
MODIFICATION TO MALE TO MALE LUER ADAPTER
| Applicant | Molded Products, Inc., Harlan IA, US |
| Decision | Substantially Equivalent, May 16, 2001 |
| Received | Dec 1, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003712
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 24, 2017 | Molded Products Inc Non-Sterile Double DIN to DIN "Y" Connector,
Product Usage:
Extension for connecting hemodialysis blood tubing to the hemodialyzer. Terminated |
KOC | None listed |
| Mar 18, 2013 | Molded Products Inc Sterile Access & Return Line Set, 36" Length, Part # UM-872-36.
Intended for use with medically prescribed hemodialysis blood tubing. Terminated |
KOC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.