# K984500: Cordis Brite Tip Catheter Sheath Introducer System

- Pathway: 510(k) (Special)
- Applicant: Cordis Corp.
- Decided: Dec 23, 1998 after 6 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
No predicates in its family tree.
26 later devices descend from it; 4 cite it directly.
4 of 27 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) Brite Tip Catheter Sheath Introducers: named in the summary without a submission number

## Most influential descendants
- K142829: Flexor Tuohy-Borst Side-Arm Introducer, Ansel Modification; Flexor Check-Flo Introducer, Ansel Modification; Flexor Check-Flo Introducers, Ansel Modification with High-Flex Dilator and Hydrophilic Coating; Flexor Check-Flo Introducer Balkin Up and Over Contralateral Design; Flexor Up and Over Balkin Contralateral Introducer; Flexor Check-Flo Introducer, Raabe Modification; Flexor Check-Flo Performer Introducer (2015), 13 descendants of its own
- K152913: GORE TIPS Set, GORE TIPS Sheath, GORE TIPS Needle (2016), 6 descendants of its own
- K020316: Cordis Trapease Permanent Vena Cava Filter with the Visease Angiographic Vessel Dilator; Models 466-P306AU & 466-P306BU (2002), 6 descendants of its own
- K171820: Transjugular Liver Access Sets (2018), 5 descendants of its own
- K034050: Cordis Optease Vena Cava Filter, Models 466-F220A and 466-F220B; Retrievable Catheter, Model 466-C220F (2004), 5 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/K984500
Methodology: https://510kreport.com/methodology