Models 432-03 & 433-03 Implant Endocard Pac Lead

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

510(k) Number

K912235 ↗

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 primary purpose of the Models 432-03 and 433-03 Implant Endocard Pac Leads, and how do they function in the body?

  These leads are designed to stimulate the heart’s electrical activity by delivering pacing impulses directly to the endocardium (the inner lining of the heart chambers). They are intended for patients with bradycardia (slow heart rate) or conduction disorders, ensuring proper heart rhythm by targeting the right ventricle or atrium through venous access during surgical implantation.

• Are the Models 432-03 and 433-03 leads reusable, and what storage guidelines should be followed to maintain sterility?

  These leads are single-use only and come pre-sterilized in sterile packaging. To preserve sterility, storage must follow the manufacturer’s guidelines, ensuring the packaging remains intact and undamaged before use. Avoid exposure to moisture, heat, or contamination.

• How do I determine if a Model 432-03 or 433-03 lead is compatible with my pacemaker pulse generator?

  Compatibility is standardized for these leads, meaning they are designed to work with approved pacemaker pulse generators under the same regulatory framework (21 CFR 870.3680). However, always verify with the manufacturer or device specifications to confirm exact sizing and connection requirements before use.

• What regulatory pathway was followed for FDA clearance of these leads, and which advisory committee was involved?

  The Models 432-03 and 433-03 underwent traditional review under the FDA’s 510(k) pathway (K912235) and were deemed substantially equivalent to predicate devices. The Cardiovascular (CV) Advisory Committee reviewed the submission, and clearance was granted under 21 CFR 870.3680 for permanent pacemaker electrodes.