Model 484-01 Bipolar Coaxial Pacing Lead

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K791377 ↗

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

  Class III

  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. →

• Is the Model 484-01 Bipolar Coaxial Pacing Lead designed for reuse or single-use in clinical procedures? Why?

  The Model 484-01 is explicitly intended for single-use implantation only. This is clearly stated in the device description, which specifies it is supplied sterile for direct use in cardiac pacing procedures without requiring reprocessing. Single-use design reduces infection risk and ensures consistent performance, aligning with best practices for implanted medical devices.

• What types of patients is this pacing lead intended to support, and how does its coaxial construction benefit them?

  This lead is designed for patients with bradyarrhythmias or conduction disorders requiring permanent cardiac pacing. The coaxial construction provides durable electrical signal transmission and mechanical stability within the heart, reducing the risk of lead failure or displacement over time. This is particularly important for long-term reliability in implanted devices.

• How is the Model 484-01 supplied, and what does that mean for surgical preparation?

  The lead is supplied sterile and ready for direct implantation, meaning it does not require additional sterilization or packaging opening in the operating room. Clinicians can proceed immediately with implantation after unpacking, minimizing procedural delays and maintaining sterile field integrity.

• Can this pacing lead be used in patients who require MRI scans, and if so, under what conditions?

  Yes, the Model 484-01 is compatible with MRI environments under specific conditions. The device labeling outlines these conditions, which typically include approved MRI protocols, field strength limits, and safe scanning parameters. Always refer to the manufacturer’s instructions for MRI compatibility details to ensure patient safety.