Biplr Im En Pac Leads (430-07, 432-03, 436-02 & 07, 438-05 & 07)

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

510(k) Number

K962174 ↗

FDA Product Code

DTB

Device Class

Class III

Regulation

21 CFR Part 870.3680

Advisory Committee

Cardiovascular

FDA Decision

ST

• 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 leads reusable or intended for single-use only, and how should they be handled before implantation?

  These leads are explicitly designed for single-use only and are supplied sterile by the manufacturer. They must remain in their sterile packaging until immediately before implantation to ensure proper infection control and functionality.

• What models are available, and how do they differ in terms of application or design?

  The Bipolar Implantable Endocardial Pacing Leads come in five distinct models: 430-07, 432-03, 436-02 & 07, and 438-05 & 07. While the exact differences in design or application aren’t specified, each model is tracked individually under FDA regulations, indicating potential variations in lead characteristics (e.g., length, electrode configuration, or pacing thresholds) tailored for specific clinical needs.

• How should these leads be stored, and what are the key considerations for maintaining their integrity?

  Since these leads are sterile and single-use, they should be stored in their original, unopened packaging in a clean, dry environment away from direct sunlight or extreme temperatures. The packaging must remain intact until use to preserve sterility and prevent contamination.

• What regulatory pathway was followed for FDA clearance, and how does this affect their use in clinical settings?

  These leads were cleared via the FDA 510(k) process (K962174) under the Class 3 device classification, with a product code of DTB (Permanent Pacemaker Electrodes). This means they underwent a premarket submission to demonstrate substantial equivalence to a legally marketed predicate device, ensuring compliance with safety and performance standards for long-term cardiac pacing applications.