# K965211: Vista Brite Tip Catheters

- Pathway: 510(k) (Traditional)
- Applicant: Cordis Corp.
- Decided: Mar 11, 1997 after 74 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 1 cites it directly.
2 of 7 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
- K034050: Cordis Optease Vena Cava Filter, Models 466-F220A and 466-F220B; Retrievable Catheter, Model 466-C220F (2004), 5 descendants of its own
- K162875: Sentry IVC filter (2017), 2 descendants of its own
- K173236: Sentry IVC Filter (2018), 1 descendant of its own
- K091077: Optease Vena Cava Filter and Retrieval Catheter (2010), 1 descendant of its own
- K181202: Sentry IVC Filter (2018), 0 descendants of its own

## Indications for use
Vista Brite Tip: The 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/K965211
Methodology: https://510kreport.com/methodology