ACS HT Balance Middleweight Guide Wire

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K983033 ↗

FDA Product Code

DQX

Device Class

Class II

Regulation

21 CFR Part 870.1330

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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See all devices from Guidant Corp. →

• What is the ACS HT Balance Middleweight Guide Wire used for?

  This guide wire is designed specifically for percutaneous coronary interventions (PCI), where it assists in navigating and positioning catheters within coronary arteries. Its balanced torque and middleweight construction enhance maneuverability, making it ideal for complex coronary anatomies during angioplasty procedures. The design minimizes vessel trauma while supporting the delivery of interventional tools.

• Is the ACS HT Balance Middleweight Guide Wire sterile?

  No, the ACS HT Balance Middleweight Guide Wire is supplied as a non-sterile device. It is intended for single-use only by healthcare professionals, so sterility is not a requirement for its intended use. Standard medical device protocols should be followed to maintain its integrity until use.

• Can this guide wire be used in an MRI environment?

  No, this guide wire is not suitable for MRI environments due to its metallic components. The presence of metal can pose significant safety risks, including heating or displacement, during MRI procedures. Always verify compatibility with the specific MRI system and environment before use.

• How should the ACS HT Balance Middleweight Guide Wire be stored?

  Storage should adhere to standard medical device protocols to preserve the device’s integrity until use. This includes keeping it in a clean, dry environment, protected from physical damage, and away from extreme temperatures or direct sunlight. Follow manufacturer guidelines for packaging and handling to ensure optimal performance.

• What regulatory pathway was followed for this guide wire?

  The ACS HT Balance Middleweight Guide Wire was cleared through the FDA’s 510(k) pathway under reference number K983033. It was reviewed under the traditional review pathway with input from the Cardiovascular (CV) advisory committee and is classified as substantially equivalent to a predicate device. The product code assigned is DQX.