# K991898: Ultra-Select Guidewire, Hytek Guidewire

- Pathway: 510(k) (Special)
- Applicant: Microvena Corp.
- Decided: Jun 16, 1999 after 12 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: 2 generations back to K922060 (1993). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K943390: Flexfinder Guidewire, Flexmedics (1995) Summary page 1.
- K991194: Modification to Ultra-Select Guidewire, Microvena Corp. (1999) Summary page 1.

## Most influential descendants
- K031442: PBN Guidewires (2003), 0 descendants of its own

## Indications for use
The 0.035” and 0.025” Hytek guidewire is indicated for use in the peripheral vasculature. The 0.014”. 0.016”, and 0.018” HyTek Guidewires are indicated for use in the peripheral and coronary vasculature.

Source page: https://510kreport.com/device/K991898
Methodology: https://510kreport.com/methodology