# K993000: Bard Hydrophilic Coated Guide Wires

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Nov 2, 1999 after 56 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 K974713 (1998). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974713: Bard Hydrophillic Coated Guide Wire, C.R. Bard, Inc. (1998) Summary page 2.
- (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
- K120119: Sunmed Guide Wire (2012), 0 descendants of its own

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

Source page: https://510kreport.com/device/K993000
Methodology: https://510kreport.com/methodology