# K143412: ADROIT Guiding Catheter

- Pathway: 510(k) (Special)
- Applicant: Cordis Corporation
- Decided: Jan 14, 2015 after 47 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
Longest line of descent: 1 generation back to K000715 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000715: Envoy and Vista Brite Tip, Cordis Corp. (2000) Summary page 4.

## Recalls of this device
- Feb 7, 2019 · Class III · Z-1198-2019: Frayed pieces of the mounting card being inside the primary packaging.

## Indications for use
The ADROIT™ Guiding Catheter is intended for use for intravascular introduction of interventional / diagnostic devices into the coronary or peripheral vascular systems.

Source page: https://510kreport.com/device/K143412
Methodology: https://510kreport.com/methodology