# K152819: Amecath Peripheral inserted Central Venous Catheter Sets

- Pathway: 510(k) (Traditional)
- Applicant: Ameco Medical Industries
- Decided: Feb 5, 2016 after 130 days
- Product code: LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days)
- Device class: 2
- Regulation: 21 CFR 880.5970
- 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 Peripheral Inserted Central Venous Catheter Sets are intended for use in attaining access to the central venous system for short or long-term use for venous pressure monitoring, blood sampling, administration of drugs and fluids, and for use with power injectors for delivery of contrast in CT studies. The catheter is indicated for multiple injections of contrast media through a power injector. The maximum pressure limit setting for Power Injectors used with the catheter may not exceed 300 psi and the flow rate may not exceed the maximum flow rate indicated.

Source page: https://510kreport.com/device/K152819
Methodology: https://510kreport.com/methodology