# K974448: Cordis Brite Tip Catheter Sheath Introducer System

- Pathway: 510(k) (Traditional)
- Applicant: Cordis Corp.
- Decided: Feb 6, 1998 after 73 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K954595 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971608: Cordis Brite Tip Catheter Sheath Introducer System, Cordis Corp. (1997) Summary page 1.

## Indications for use
Cordis Catheter Sheath Introducers are intended for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices.

Source page: https://510kreport.com/device/K974448
Methodology: https://510kreport.com/methodology