# K981381: Acs HI-Torque Cross-IT Guide Wire with Hydrocoat Hydrophilic Coating Product Family Models 1003211H,1003212HJ,1003213H,1

- Pathway: 510(k) (Traditional)
- Applicant: Guidant Corp.
- Decided: Jul 15, 1998 after 90 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.
190 later devices descend from it; 2 cite it directly.
3 of 191 devices 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 TRAVERSE® Guide Wire with HYDROCOAT™ Hydrophilic Coating: named in the summary without a submission number

## Most influential descendants
- K990639: Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with Hydrocoat Hydrophilic Coating. (1999), 189 descendants of its own
- K022762: Jowire Neo's Ptca Catheter Guidewires, Models AG141000, AG142000, AG143000, AG141002, AG141010, AG14M060 & AG14M050 (2002), 104 descendants of its own
- K031277: Jowire Asahi Ptca Catheter Guide Wires, Models AG145300,141300,142300,132200,14M350,14M345,14M360,143390,141002 (2003), 92 descendants of its own
- K041531: Asahi Ptca Guide Wire Confianza Pro (2004), 79 descendants of its own
- K011986: Safe-Steer Guide Wire System (2002), 76 descendants of its own

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

Source page: https://510kreport.com/device/K981381
Methodology: https://510kreport.com/methodology