# K082094: Bard Ptfe (Teflon) Coated Guide Wires

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard Inc., Bard Electrophysiology Division
- Decided: Dec 17, 2008 after 146 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 K772021 (1977). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
1 of 5 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K772021: TRC Stainless Steel Safety Spring Guides, Usci, Div. C.R. Bard, Inc. (1977) Summary page 2.
- K780438: Safety Spring Guides, Teflon Coated, C.R. Bard, Inc. (1978) Summary page 2.
- (no number) Bard Preamendment Guide Wires: named in the summary without a submission number

## Most influential descendants
- K160785: Worker Guidewire (2016), 0 descendants of its own
- K120119: Sunmed Guide Wire (2012), 0 descendants of its own

## Indications for use
Bard Guide Wires Indication: Bard PTFE Coated Guide Wires are indicated for percutaneous entry of a guiding catheter into a vessel using standard percutaneous methods (Seldinger's Technique). Generally, Guide Wires which are 100cm or longer are indicated for use with vascular catheters and balloon dilatation catheters in angiographic or interventional procedures. The guide wire may be inserted through an [18g] needle, introducer, or catheter. A guide wire with an outer diameter of .018" or smaller may be used with open ended guide wires. Guide wires which are shorter than 100cm are generally indicated for non-vascular use. Guide wires with an outer diameter of .018" or smaller may be inserted into the target organ through a [22g] needle or an open-ended guide wire (60cm or shorter), Larger guide wires may be inserted through larger gauge needles or an introducer for placement of dilators and/or drainage catheters.

Source page: https://510kreport.com/device/K082094
Methodology: https://510kreport.com/methodology