ONTRAC Steerable Guidewire

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

510(k) Number

K941229 ↗

FDA Product Code

DQX

Device Class

Class II

Regulation

21 CFR Part 870.1330

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Cardiovascular Spring Guides Open recall

  Class II

  FDA 510(k) K770977 Active Cleared 14 Jun 1977

• Lrm Produces Guidewires on an Oem Basis for Manufacturers, Kit Assemblers, and Distributors.

  Class II

  FDA 510(k) K960866 Active Cleared 5 Apr 1996

• Lake Region Variable Stiffness Guidewire (Vsgw)

  Class II

  FDA 510(k) K871882 Active Cleared 15 Sep 1987

• Fasiculated Nail

  Class II

  FDA 510(k) K861365 Active Cleared 6 May 1986

• Torque Handle Device for Guidewire

  Class II

  FDA 510(k) K905639 Active Cleared 20 Feb 1991

• Steerable Guidewire

  Class II

  FDA 510(k) K022813 Active Cleared 14 Feb 2003

See all devices from Lake Region Mfg., Inc. →

• What types of medical procedures is the ONTRAC Steerable Guidewire designed to assist with, and where in the body is it primarily used?

  The ONTRAC Steerable Guidewire is specifically engineered to aid in cardiovascular procedures, helping clinicians navigate and position catheters and interventional devices within the coronary and peripheral vasculature. This includes applications in coronary arteries as well as peripheral arteries like the renal arteries, where precise guidance is critical for successful interventions.

• Is the ONTRAC Steerable Guidewire intended for single-use or repeated use, and what does this mean for clinical workflows?

  The ONTRAC Steerable Guidewire is supplied as a single-use device, meaning it is designed for one-time use in a single patient procedure. This design choice helps ensure patient safety by minimizing the risk of cross-contamination and reduces the need for reprocessing, streamlining clinical workflows and ensuring consistent performance per use.

• What does the non-sterile classification of the ONTRAC Steerable Guidewire imply for how it should be handled before use in a procedure?

  Since the ONTRAC Steerable Guidewire is non-sterile, it must be sterilized by the healthcare facility prior to use in a procedure. This typically involves terminal sterilization using methods like ethylene oxide gas, steam, or other approved techniques, ensuring it meets sterile standards before insertion into a patient’s vasculature.

• What regulatory pathway was followed for the FDA clearance of the ONTRAC Steerable Guidewire, and what does this mean for its safety and performance?

  The ONTRAC Steerable Guidewire received FDA clearance through the Traditional 510(k) Review Process, with a decision date of May 12, 1994. This pathway demonstrates that the device was evaluated for substantial equivalence to a legally marketed predicate device, ensuring it meets established safety and performance standards for use in angiographic procedures as intended.