# K902256: Irrigation Catheter 4, 6 and 10 French

- Pathway: 510(k) (Traditional)
- Applicant: Applied Vascular Devices, Inc.
- Decided: Feb 15, 1991 after 270 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: 1 (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
- Aug 9, 2012 · Class II · Z-2448-2012: Applied Medical is recalling specific lot numbers of its Vascular Catheters because they may have a potential for packaging particulate matter to reside on the product.

Source page: https://510kreport.com/device/K902256
Methodology: https://510kreport.com/methodology