Models 438-05 and 435-05 Implantable Pacing Lead

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

510(k) Number

K922972 ↗

FDA Product Code

DTB

Device Class

Class III

Regulation

21 CFR Part 870.3680

Advisory Committee

Cardiovascular

FDA Decision

SESP Substantially Equivalent — Postmarket Surveillance

• 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 designed for reuse or intended as single-use implants, and how should they be handled to maintain sterility?

  The Models 438-05 and 435-05 Implantable Pacing Leads are sterile, single-use devices intended for permanent implantation in the cardiovascular system. They must be handled and stored according to the manufacturer’s guidelines to preserve sterility, as they are not meant for reuse. Proper storage and sterile surgical techniques are critical to ensure patient safety and device functionality.

• What types of heart conditions are these leads typically used to treat, and how do they work?

  These leads are designed for electrical stimulation of the heart to correct bradycardia (slow heart rate) or conduction system disorders, ensuring proper heart rhythm. They deliver pacing impulses to the heart muscle, helping it contract at a consistent, healthy rate when the natural electrical system is impaired.

• How are these leads supplied, and what should be considered when ordering or stocking them?

  The leads are supplied sterile and pre-packaged for single-use implantation. Since they require sterile surgical environments, facilities should ensure proper storage conditions (e.g., protected from moisture, extreme temperatures, or contamination) to maintain integrity. Ordering should account for the need to replace them only once per patient, as reuse is not permitted.

• What regulatory pathway was used for FDA clearance, and what ongoing compliance requirements apply?

  These leads were cleared via the FDA’s 510(k) pathway in 1993 under product code DTB (Class III) for permanent pacemaker electrodes. As a Class III device, they are subject to postmarket surveillance to monitor performance and safety after implantation, ensuring continued compliance with regulatory standards.