Model 492-01 Pacing Lead

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K844266 ↗

FDA Product Code

DTB

Device Class

Class III

Regulation

21 CFR Part 870.3680

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K823508 Active Cleared 14 Jan 1983

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  FDA 510(k) K813518 Active Cleared 12 Jan 1982

• Veri-Vu Lensometer

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  FDA 510(k) K791521 Active Cleared 30 Oct 1979

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  FDA 510(k) K801040 Active Cleared 30 Jun 1980

See all devices from Intermedics, Inc. →

• What is the Model 492-01 Pacing Lead used for in clinical practice?

  The Model 492-01 Pacing Lead is designed to deliver electrical impulses to the heart for managing bradycardia or other cardiac conduction disorders. It functions as a catheter-based electrode implanted within the heart’s chambers to regulate rhythm when connected to a pacemaker system.

• Is the Model 492-01 Pacing Lead intended for reuse or single-use?

  The Model 492-01 Pacing Lead is supplied sterile and explicitly intended for single-use implantation in a clinical setting. It is not designed for reuse after initial use.

• What regulatory pathway was followed for FDA clearance of this device?

  The Model 492-01 Pacing Lead received FDA 510K clearance under a Traditional Review pathway, determined to be substantially equivalent to a predicate device. It falls under Class III classification for cardiovascular applications and complies with 21 CFR 870.3680 standards.

• How is the Model 492-01 Pacing Lead supplied, and what should be considered for storage?

  The lead is supplied sterile and packaged for single-use. While specific storage instructions aren’t detailed here, sterile medical devices like this typically require protection from contamination (e.g., sealed packaging) and adherence to manufacturer guidelines for shelf life and environmental conditions.