# K954622: Ivt 0.014 Track or Ivt 0.014 Accutrack

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific /International Technologies
- Decided: Apr 29, 1996 after 207 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 K882804 (1988). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K895903: Ivt 0.014 Guide Wire, Intensive Technology, Inc. (1990) Summary page 1.
- K882804: 0.014 Peripheral Guide Wire, Intensive Technology, Inc. (1988) Summary page 1.
- (no number) ACS 0.014" High Torque Floppy: named in the summary without a submission number
- (no number) Cook Family of Guidewires: named in the summary without a submission number

## Indications for use
The IVT 0.014" TRACK is intended to facilitate the navigation and placement of angioplasty and interventional devices through tortuous peripheral and coronary vessels.

Source page: https://510kreport.com/device/K954622
Methodology: https://510kreport.com/methodology