# K962717: 6 French, 7 French, and 8 French Guiding Catheters with Phosphorylcholine (PC) Polymer Coating

- Pathway: 510(k) (Traditional)
- Applicant: Biocompatibles Cardiovascular, Inc.
- Decided: Feb 12, 1997 after 215 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.
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. The FDA summary names its predicate without a number.
- (no number) Cordis Corporation 6 Fr Brite Tip® Guiding Catheter: named in the summary without a submission number
- (no number) Cordis Corporation 8 Fr Brite Tip® Guiding Catheter: named in the summary without a submission number

## Indications for use
The Guiding Catheters with PC Polymer Coating are indicated to aid the percutaneous placement of guide wires, balloon dilatation catheters, and other devices required for peripheral and coronary artery transcatheter diagnosis and therapy. The guiding catheters are not intended for use in the cerebral vasculature.

Source page: https://510kreport.com/device/K962717
Methodology: https://510kreport.com/methodology