# K971608: Cordis Brite Tip Catheter Sheath Introducer System

- Pathway: 510(k) (Traditional)
- Applicant: Cordis Corp.
- Decided: Jul 21, 1997 after 81 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- 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 K954595 (1995). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954595: Cordis Brite Tip Sheath Introducer, Cordis Corp. (1995) Summary page 1.

## Most influential descendants
- K974448: Cordis Brite Tip Catheter Sheath Introducer System (1998), 0 descendants of its own

## Recalls of this device
- May 5, 2003 · Not classified · Z-0941-03: Reports of broken or separated tips of the catheter sheath introducers.

## 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/K971608
Methodology: https://510kreport.com/methodology