Endocaridal Pacing Lead Unipolar 477

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K781525 ↗

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 is the Endocardial Pacing Lead Unipolar 477 used for in clinical practice?

  This device is designed for endocardial placement to deliver pacing stimuli directly to the heart’s inner lining. It works with external pacemakers to regulate cardiac rhythm in patients experiencing arrhythmias, ensuring consistent electrical impulses to maintain proper heart function.

• Is the Endocardial Pacing Lead Unipolar 477 intended for reuse, or is it single-use only?

  The lead is sterile upon supply and intended for single-use implantation only. Reuse is not recommended to preserve sterility and functionality, as outlined in the manufacturer’s guidelines.

• How should I store this device to ensure it remains effective and sterile?

  The lead must be stored according to manufacturer-provided instructions to maintain sterility and functionality. Since it is sterile upon supply and single-use, proper packaging integrity and environmental controls (e.g., temperature, humidity) are critical before implantation.

• What regulatory pathway was followed for this device’s approval, and which committee reviewed it?

  The Endocardial Pacing Lead Unipolar 477 received FDA 510(k) clearance (K781525) under the Traditional pathway, with a decision of *Substantially Equivalent* (SESE). The review was conducted by the Cardiovascular (CV) Advisory Committee, reflecting its classification as a Class III device under FDA regulation 870.3680.