Acs Hi-Torque Cross-It Guide Wire with Hydrocoat Hydrophilic Coating Product Family Models 1003211H, 1003212HJ, 1003213H, 1

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K981381 ↗

FDA Product Code

DQX

Models / Variants

1003211H

1003212HJ

1003213H

1

Device Class

Class II

Regulation

21 CFR Part 870.1330

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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• Hi-Torque Balance Iniversal Guide Wire with Hydrocoat Hydrophilic Coating

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See all devices from Guidant Corp. →

• What is the ACS Hi-Torque Guide Wire used for?

  The ACS Hi-Torque Guide Wire is intended for use in cardiovascular applications, facilitating delivery and maneuverability during vascular procedures.

• What are the key features of the Hydrocoat hydrophilic coating?

  The Hydrocoat hydrophilic coating is applied to the distal portion of the guide wire, while the proximal section is coated with polytetrafluoroethylene to facilitate delivery and maneuverability.

• How is the device supplied and what models are available?

  The device is supplied as part of a product family, including models 1003211H, 1003212HJ, 1003213H, and 1, with varying configurations such as straight or J-shaped.

• What is the regulatory status of the ACS Hi-Torque Guide Wire?

  The device was cleared by the FDA through the 510(k) process under K981381, determined to be substantially equivalent.