# K060666: Carotid Access Kit

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Medical Corp.
- Decided: Jun 29, 2006 after 107 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 K924607 (1993). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K863138: Terumo Radifocus Guide Wire, Terumo Medical Corp. (1986) Summary page 1.
- K915414: Terumo Angiogtaphic Catheter, Terumo Medical Corp. (1992) Summary page 1.
- K012812: Carotid Guiding Sheath, Terumo Medical Corp. (2001) Summary page 1.

## Indications for use
The Glidewire® guide wire is designed to direct a catheter to the desired anatomical location, including but not limited to the carotid arteries, during diagnostic or interventional procedures. The GlideCath ® XP catheter is intended for use in angiographic procedures. It delivers radiopaque media and therapeutic agents to selected sites in the vascular system, including but not limited to the carotid arteries. The Destination® Carotid Guiding Sheath is intended for the introduction of interventional and diagnostic devices into the human vasculature including but not limited to the carotid arteries.

Source page: https://510kreport.com/device/K060666
Methodology: https://510kreport.com/methodology