Model 493-03 Pacing Lead

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K844264 ↗

FDA Product Code

DTB

Device Class

Class III

Regulation

21 CFR Part 870.3680

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Lifeline Unipolar Lead #487-05

  Class III

  FDA 510(k) K823508 Active Cleared 14 Jan 1983

• Implant Aid Splicing Crimp & Sleeve

  Class III

  FDA 510(k) K813518 Active Cleared 12 Jan 1982

• Veri-Vu Lensometer

  Class I

  FDA 510(k) K791521 Active Cleared 30 Oct 1979

• Implantable Pulse Generator Pacemakers

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  FDA 510(k) K791568 Active Cleared 19 Sep 1979

• Model 480-01 Pacing Lead

  Class III

  FDA 510(k) K844270 Active Cleared 28 Mar 1985

• GE Lead Adapter, Model 345-01

  Class II

  FDA 510(k) K801040 Active Cleared 30 Jun 1980

See all devices from Intermedics, Inc. →

• What is the Model 493-03 Pacing Lead used for in clinical practice?

  The Model 493-03 Pacing Lead is designed to deliver electrical impulses from an implanted pacemaker to the heart, helping regulate abnormal heart rhythms (arrhythmias) in patients who require cardiac pacing. It is specifically intended for single-use implantation during cardiac procedures to ensure reliable signal transmission and compatibility with pacing systems.

• Is the Model 493-03 Pacing Lead meant for reuse or is it single-use?

  The Model 493-03 Pacing Lead is explicitly intended for single-use implantation only. It is supplied sterile and must not be reused after a single procedure to maintain safety and performance standards.

• How is the Model 493-03 Pacing Lead regulated, and what does that mean for its use?

  The Model 493-03 Pacing Lead is classified as a Class III medical device under FDA regulations and has received 510(k) clearance (K844264). This classification means it undergoes rigorous review by the FDA’s Cardiovascular (CV) Advisory Committee to ensure safety and effectiveness. Its clearance indicates it is considered substantially equivalent to a predicate device, allowing it to be legally marketed in the U.S. for its intended use.

• What storage or handling precautions should be taken with the Model 493-03 Pacing Lead?

  While the provided data does not specify exact storage conditions, the lead is supplied sterile and must be handled in a manner that maintains sterility until implantation. It should be stored according to standard sterile medical device protocols—typically in a clean, dry environment away from direct sunlight or extreme temperatures—until ready for use in a surgical setting.