# K131225: Adroit Guiding Catheter

- Pathway: 510(k) (Special)
- Applicant: Cordis Corp., A Johnson & Johnson Co.
- Decided: May 29, 2013 after 29 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 12, 2013 · Class II · Z-0003-2014: Due to a labeling error related to the conversion of the inner diameter of the catheter from inches to millimeters. The English dimension is correct and is the primary dimension.

Source page: https://510kreport.com/device/K131225
Methodology: https://510kreport.com/methodology