# K110793: Amecath and Amecath Uniqath Soft Short Term Dual Hemodialysis Catheterization Kits

- Pathway: 510(k) (Traditional)
- Applicant: Ameco Medical Industries
- Decided: Dec 16, 2011 after 269 days
- Product code: MPB (Catheter, Hemodialysis, Non-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
Indicated for acute hemodialysis and apheresis. They may be inserted percutaneously and are ideally placed in the internal jugular vein. Although these catheters may be inserted into the subclavian or femoral vein, the internal jugular is the preferred site.

Source page: https://510kreport.com/device/K110793
Methodology: https://510kreport.com/methodology