# K972978: Vista Brite Tip Guiding Catheters

- Pathway: 510(k) (Traditional)
- Applicant: Cordis Corp.
- Decided: Oct 21, 1997 after 71 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.
3 later devices descend from it; 3 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Cordis Vista Brite Tip: named in the summary without a submission number
- (no number) Cordis Endovascular Systems, ENVOY Guiding Catheters: named in the summary without a submission number

## Most influential descendants
- K161546: R2P SlenGuide (2016), 0 descendants of its own
- K153703: Guiding Catheter (2016), 0 descendants of its own
- K102979: Nexgen Peripheral Guide Catheter (2011), 0 descendants of its own

## 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 guiding catheter is intended for use for intravascular introduction of interventional/diagnostic devices into the coronary and peripheral vascular systems.

Source page: https://510kreport.com/device/K972978
Methodology: https://510kreport.com/methodology