Model 486-01 Pacing Lead

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K844259 ↗

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. →

• What types of heart conditions is the Model 486-01 Pacing Lead designed to address, and how does it work?

  The Model 486-01 Pacing Lead is specifically designed for patients with bradycardia or conduction disorders, where the heart beats too slowly or fails to conduct electrical impulses properly. It works by delivering electrical stimulation directly to the myocardium (heart muscle) through surgical implantation in the cardiovascular system, ensuring consistent pacing pulses to maintain a proper heart rhythm.

• Is the Model 486-01 Pacing Lead reusable, or is it intended for single-use only?

  The Model 486-01 Pacing Lead is explicitly intended for single-use implantation only. Once implanted, it is not designed to be removed or reused, as it is a permanent pacemaker electrode. Surgical implantation by a healthcare professional is required, and it is supplied sterile for immediate use.

• What storage or handling requirements should I follow for the Model 486-01 Pacing Lead before implantation?

  The Model 486-01 Pacing Lead is supplied sterile and must be stored according to manufacturer guidelines to maintain sterility. Since it is intended for surgical implantation, it should be kept in its original packaging until use, protected from contamination, and handled with sterile techniques in a clinical setting. Always refer to the included instructions for specific storage conditions.

• Does the Model 486-01 Pacing Lead have any restrictions regarding MRI use, and why?

  The Model 486-01 Pacing Lead does not specify any MRI safety restrictions in its documentation. However, this does not imply it is MRI-compatible. Pacemaker leads can pose risks during MRI procedures due to potential interference with pacing function or heating effects. Always consult the manufacturer’s latest guidelines and clinical protocols before considering MRI exposure for patients with implanted pacing leads.

• How do I verify the regulatory compliance of the Model 486-01 Pacing Lead before purchasing or using it?

  The Model 486-01 Pacing Lead holds FDA 510(k) clearance (K844259) under the classification of a permanent pacemaker electrode (21 CFR 870.3680). To verify compliance, check the device’s registration number (e.g., 2017865) in the FDA’s OpenFDA database or confirm the clearance status via the FDA’s [510(k) database](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm). Always ensure the lot or batch you receive matches the approved specifications.