# K974713: Bard Hydrophillic Coated Guide Wire

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Oct 14, 1998 after 301 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
No predicates in its family tree.
3 later devices descend from it; 2 cite 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)
- None. The FDA summary names its predicate without a number.
- (no number) Bard® Preamendment Angiographic Guide Wires: named in the summary without a submission number
- (no number) Bard® PTCA Steerable Standard Guide Wire: named in the summary without a submission number
- (no number) Bard® Silk™ Guide Wire: named in the summary without a submission number
- (no number) Terumo Glidewire™: named in the summary without a submission number

## Most influential descendants
- K993000: Bard Hydrophilic Coated Guide Wires (1999), 1 descendant of its own
- K120119: Sunmed Guide Wire (2012), 0 descendants of its own
- K992237: Medtronic GT2 Fusion Guide Wires (1999), 0 descendants of its own

## Indications for use
Hydrophilic Coated Angiography Guide Wires are indicated for use for percutaneous entry into a vessel using the Seldinger technique. Hydrophilic Coated Angioplasty (PTCA) Guide Wires are steerable guidewires that are used for the introduction and placement of diagnostic or interventional devices in the coronary and peripheral vasculature and may be used to reach and cross a target lesion.

Source page: https://510kreport.com/device/K974713
Methodology: https://510kreport.com/methodology