Model 490-01 Pacing Lead

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K844261 ↗

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

  Class I

  FDA 510(k) K791521 Active Cleared 30 Oct 1979

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  FDA 510(k) K844270 Active Cleared 28 Mar 1985

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  Class II

  FDA 510(k) K801040 Active Cleared 30 Jun 1980

See all devices from Intermedics, Inc. →

• What is the primary purpose of the Model 490-01 Pacing Lead, and how does it function within the body?

  The Model 490-01 Pacing Lead is a bipolar sensing lead designed for permanent implantation in the cardiovascular system. It delivers electrical impulses to regulate heart rate and senses cardiac activity, supporting pacing therapy for patients who require heart rate regulation. This lead is specifically intended for use with implantable cardiac pacemakers to ensure proper electrical stimulation and monitoring of the heart.

• Is the Model 490-01 Pacing Lead intended for single-use or reusable applications, and how is it supplied?

  The Model 490-01 Pacing Lead is sterile and intended for single-use implantation only. It is supplied pre-sterilized for clinical use, ensuring safety and sterility upon first use in a controlled medical setting. Reuse is not recommended or supported by the manufacturer.

• What regulatory pathway was followed for FDA clearance of this device, and when was it approved?

  The Model 490-01 Pacing Lead received FDA 510(k) clearance under the Traditional pathway with a decision date of March 28, 1985. The clearance was granted as substantially equivalent to a predicate device, and the submission was reviewed by the Cardiovascular (CV) Advisory Committee. The device classification is Class III under FDA regulation 870.3680.

• Are there multiple sizes or models available for the Model 490-01 Pacing Lead, or is it a single standardized design?

  The provided data does not specify multiple sizes or models for the Model 490-01 Pacing Lead. It is described as a single standardized bipolar sensing lead designed for permanent implantation in the cardiovascular system. For exact specifications like lead length or electrode configuration, refer to the manufacturer’s technical documentation.