# K971688: Ivt 0.014 Ptfe-Coated Trackwire

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific /International Technologies
- Decided: Dec 11, 1997 after 218 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.
No later device cites it as a predicate yet.
0 of 1 device 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) IVT 0.014" Trackwire: named in the summary without a submission number
- (no number) ACS Hi-Torque Guide Wires with Microglide Coating: named in the summary without a submission number
- (no number) Cordis Stabilizer Guidewires with Duraglide PTFE Coating: named in the summary without a submission number

## Indications for use
The IVT 0.014" PTFE-Coated Trackwire is indicated for use in coronary and peripheral vessels to facilitate the navigation and placement of angioplasty interventional catheters. The 0.014" Trackwire is not indicated for cerebrovascular use.

Source page: https://510kreport.com/device/K971688
Methodology: https://510kreport.com/methodology