Model 482-01 Bipolar Coaxial Pacing Lead

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K791378 ↗

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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See all devices from Intermedics, Inc. →

• What is the primary purpose of the Model 482-01 Bipolar Coaxial Pacing Lead and how does its design support that function?

  The Model 482-01 is designed to deliver electrical impulses to the heart muscle, helping maintain proper cardiac rhythm by stimulating contractions when needed. Its bipolar coaxial construction improves signal reliability and mechanical durability, which is critical for long-term pacing applications. This design reduces interference and ensures consistent pacing performance over extended use.

• Is this device intended for repeated use, or is it meant to be implanted as a permanent solution?

  This device is sterile and intended for single-use implantation in the cardiovascular system. It is classified as a permanent pacemaker electrode, meaning it is meant to be left in place long-term to provide continuous pacing support.

• What regulatory pathway was followed for FDA clearance of this device, and what does that mean for its use?

  The Model 482-01 was cleared through the FDA 510(k) process (K791378) with a Substantially Equivalent (SESE) determination, meaning it was deemed comparable to a legally marketed predicate device. This clearance confirms its compliance with FDA standards for permanent pacemaker electrodes under regulation 870.3680, ensuring it meets safety and effectiveness requirements for cardiac pacing.

• Are there any special handling or storage instructions provided for this device?

  The device is supplied sterile for single-use, but no additional storage or MRI safety specifications are explicitly mentioned in the provided data. Standard sterile medical device handling practices should be followed, including protection from contamination and physical damage before implantation.