# K110794: Amecath CVC and Amecath Pressure CVC Short Term Single and Multi-Lumen Catherization Kits

- Pathway: 510(k) (Traditional)
- Applicant: Ameco Medical Industries
- Decided: Dec 21, 2011 after 274 days
- Product code: FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days)
- Device class: 2
- Regulation: 21 CFR 880.5200
- 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 to permit short-term (<30 day) central venious access for the treatment of diseases or conditions requiring central venous access, including, but not limited to the following: * Lack of usable peripheral IV sites * Central venious pressure monitoring * Total parenterall nutrition (TPN) * Multiple infusions of fluids, medications, or chemotherapy * Frequent blood sampling or receiving blood transfusions/blood products * Infusions that are hypertonic, hyperosmolar, or infusions that have divergent pH values in pressure CVC only * Injection of contrast media When used for pressure injection of contrast media, do not exceed the maximumn indicated flow rate for each cahtrlmn Th maium pressure of power injector equipment used with the pressure injectable CVC may not exceed 300psi.

Source page: https://510kreport.com/device/K110794
Methodology: https://510kreport.com/methodology