# K123943: Amecath Dual Lumen Hemodialysis Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Ameco Medical Industries
- Decided: Apr 2, 2013 after 103 days
- Product code: MSD (Catheter, Hemodialysis, Implanted)
- Device class: 2
- Regulation: 21 CFR 876.5540
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
"Amecath Dual Lumen Implanted Hemodialysis Catheter" is designed for chronic hemodialysis and apheresis. It is a radiopaque polyurethane catheter designed for percutaneous insertion or insertion via cutdown. Repair Kit is designed to replace worn or damaged extension connector adapters on the all catheter models: * PDLC * PYDLC * P2TC * PXDLC Catheters are not intended for pediatric use.

Source page: https://510kreport.com/device/K123943
Methodology: https://510kreport.com/methodology