Lifeline Pacing Leads #471-07 & #09

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K832409 ↗

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. →

• Are these pacing leads reusable or intended for single-use only, and why does that matter for clinical practice?

  The Lifeline Pacing Leads #471-07 & #09 are explicitly designed for single-use implantation and are supplied sterile. This ensures patient safety by preventing cross-contamination and maintaining device integrity, as reuse could compromise sterility and lead performance over time. Single-use also aligns with clinical best practices for implantable cardiac devices to minimize infection risks.

• What types of patients or clinical scenarios would these leads be used in, based on their design?

  These leads are intended for patients requiring chronic cardiac pacing support, such as those with bradycardia (slow heart rate) or conduction system disorders. They are part of implantable pacemaker systems and regulate heart rhythm by delivering electrical impulses directly to the heart muscle. Clinicians would use them in procedures where long-term pacing is necessary, such as for patients with heart block or other chronic arrhythmias.

• How should these leads be stored before use, and what precautions should be taken?

  Since the leads are sterile, they must be stored in their original packaging until implantation to preserve sterility. The packaging should remain unopened and protected from contamination, moisture, or physical damage. Clinicians should follow manufacturer guidelines for shelf-life and storage conditions (e.g., room temperature, away from direct sunlight) to ensure device functionality and safety before use.

• Are there any known restrictions on using these leads in patients who require MRI scans?

  The available data does not specify MRI safety restrictions for the Lifeline Pacing Leads #471-07 & #09. However, as with all implantable cardiac devices, MRI use should be carefully evaluated on a case-by-case basis by the treating physician. If MRI is required, the risks versus benefits must be weighed, and the lead’s compatibility with magnetic fields should be confirmed with the manufacturer or clinical guidelines.