# K954642: Hydro-Select Guidewire

- Pathway: 510(k) (Traditional)
- Applicant: Microvena Corp.
- Decided: Dec 17, 1996 after 434 days
- Product code: DQX (Wire, Guide, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1330
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K935232 (1994). 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)
- K935232: Hydrotorque Guide Wire, Kingston Technologies, Inc. (1994) Summary page 1.
- K952860: The Niner Nitinol Guidewire, Microvena Corp. (1995). Cleared while this submission was under review Summary page 1.
- K946356: M-Path Nitinol Guidewire, Microvena Corp. (1995) Summary page 1.
- (no number) ACS HI-TORQUE Guidewires: named in the summary without a submission number

## Indications for use
The HyTek Guidewire is intended for general intravascular use to aid in the selective placement of catheters in the coronary and peripheral and visceral vasculature during diagnostic and/or therapeutic procedures.

Source page: https://510kreport.com/device/K954642
Methodology: https://510kreport.com/methodology