# K992169: Acs HI-Torque Cross-IT 400XT Guide Wire

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Cardiovascular Systems, Inc.
- Decided: Oct 28, 1999 after 122 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) HI-TORQUE CROSS-IT™ 300XT Guide Wire with HYDROCOAT™ Hydrophilic Coating: named in the summary without a submission number
- (no number) Wholey Hi-Torque Standard® 0.035" Guide Wire: named in the summary without a submission number
- (no number) Commander, Standard, Steerable Guide Wire: named in the summary without a submission number

## Indications for use
To facilitate the placement of balloon dilatation catheters during percutancous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA).

Source page: https://510kreport.com/device/K992169
Methodology: https://510kreport.com/methodology