Lifeline Endocardial Unipolar Lead 483-08

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K853517 ↗

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 this lead reusable or intended for single-use only, and how does that affect its handling in a clinical setting?

  The Lifeline Endocardial Unipolar Lead 483-08 is explicitly designed for single-use implantation and is supplied sterile. This means it must not be reused after one procedure to maintain patient safety and sterility. Clinicians should follow standard sterile field protocols during implantation, as the lead is not intended for reprocessing or reuse.

• What are the key considerations for storage of this device before implantation?

  Since the lead is supplied sterile, it should be stored in its original packaging until ready for use to preserve sterility. The packaging is likely sealed and designed to protect the device from contamination. Always check the manufacturer’s labeling for specific storage conditions, such as temperature or humidity restrictions, though none are explicitly mentioned in the provided data.

• Does this lead come in multiple sizes or models, or is there only one version available?

  The Lifeline Endocardial Unipolar Lead 483-08 is available only in a single model number (483-08). This model is designed specifically for endocardial pacing applications, meaning it is not interchangeable with other lead types or sizes unless explicitly stated by the manufacturer. Always verify compatibility with the pacemaker system being used.

• What regulatory pathway was followed for FDA clearance, and what does that mean for clinicians?

  The lead received FDA 510(k) clearance under the Traditional Review pathway, determined to be substantially equivalent to a predicate device. This means the FDA reviewed it against an existing approved lead and confirmed it meets safety and effectiveness standards for permanent pacemaker electrode use. Clinicians can rely on this clearance as evidence of regulatory scrutiny, though they should always refer to the device’s labeling for specific instructions.