Model 438-03 Cardifix Side Hook Implant Pace Lead

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K875100 ↗

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 Model 438-03 Cardifix Side Hook Implant Pace Lead, and how does its design support that purpose?

  The Model 438-03 Cardifix Side Hook Implant Pace Lead is designed specifically for permanent cardiac pacing procedures. Its side hook mechanism ensures secure fixation within the heart, providing stable electrical contact for reliable pacing therapy. This design helps prevent lead dislodgement, which is critical for long-term pacing effectiveness.

• Is this device intended for reuse, or is it meant to be used only once during a single procedure?

  The Model 438-03 Cardifix Side Hook Implant Pace Lead is supplied sterile and intended for single-use implantation only. Single-use design ensures patient safety by eliminating risks associated with reprocessing, such as contamination or degradation of performance.

• How was this device’s regulatory pathway determined, and what does that mean for its use in clinical settings?

  The Model 438-03 was cleared through the FDA’s 510(k) pathway in 1988, classified as a Class III medical device under product code DTB. This means it underwent a review by the Cardiovascular (CV) Advisory Committee to demonstrate substantial equivalence to a predicate device, ensuring it meets stringent safety and effectiveness standards for surgical implantation in controlled clinical environments.

• What special considerations should clinicians take into account when handling or storing this device?

  Since the Model 438-03 is sterile and single-use, clinicians must ensure it remains unopened until immediate preoperative use. Storage should follow manufacturer guidelines to preserve sterility—typically in a clean, dry environment away from direct sunlight or extreme temperatures. Any compromised packaging should be discarded to prevent contamination risks.