# K781333: Central Catheter Tray

- Pathway: 510(k) (Traditional)
- Applicant: Argon Medical Corp.
- Decided: Oct 24, 1978 after 83 days
- Product code: KGC (Tube, Gastro-Enterostomy)
- Device class: 2
- Regulation: 21 CFR 876.5980
- Recalls of this device: 2 (0 Class I)
- 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 has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Mar 29, 2010 · Not classified · Z-1739-2010: There are 1-2 places on some of the multi-purpose kit blisters/trays in which there are holes and/or the material is so thin that holes are easily created. This would potentially cause the sterility o
- Mar 29, 2010 · Not classified · Z-1738-2010: There are 1-2 places on some of the multi-purpose kit blisters/trays in which there are holes and/or the material is so thin that holes are easily created. This would potentially cause the sterility o

Source page: https://510kreport.com/device/K781333
Methodology: https://510kreport.com/methodology