# K014195: Kayak Hydrophilic Guide Wires

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Mar 19, 2002 after 88 days
- Product code: DOX (Fluorometer, Lead (Dedicated Instruments))
- Device class: 2
- Regulation: 21 CFR 862.3550
- 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 K953533 (1995). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961445: Radifocus Glidewire for Coronary Use with Platinum (or Gold) Coil, Terumo Medical Corp. (1996) Summary page 1.
- K973845: Cordis Hydronol Steerable Guidewire, Cordis Corp. (1998) Summary page 1.

## Indications for use
The Boston Scientific Corporation (BSC) Kayak™ Hydrophilic Guide Wires are intended to facilitate the placement of a catheter during diagnostic or interventional procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches. This device is not intended for use in the coronary arteries or the neurovasculature.

Source page: https://510kreport.com/device/K014195
Methodology: https://510kreport.com/methodology