# K991194: Modification to Ultra-Select Guidewire

- Pathway: 510(k) (Special)
- Applicant: Microvena Corp.
- Decided: May 5, 1999 after 27 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 K922060 (1993). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K922060: .25' Ultra-Select Guidewire, Microvena Corp. (1993) Summary page 1.

## Most influential descendants
- K991898: Ultra-Select Guidewire, Hytek Guidewire (1999), 1 descendant of its own
- K031442: PBN Guidewires (2003), 0 descendants of its own

## Indications for use
The 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 vascularure.

Source page: https://510kreport.com/device/K991194
Methodology: https://510kreport.com/methodology