Model 435-02 Cardifix Implantable Pacing Lead

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K862276 ↗

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 435-02 Cardifix Implantable Pacing Lead, and how does it function in the body?

  The Model 435-02 Cardifix Implantable Pacing Lead is designed to deliver electrical stimulation to the heart, helping maintain proper cardiac rhythm in patients with bradycardia or conduction disorders. It achieves this by transmitting pacing impulses through an implanted lead system, ensuring consistent electrical signals to regulate heartbeats.

• Is the Model 435-02 Cardifix Implantable Pacing Lead intended for reuse, or is it meant to be used only once?

  The Model 435-02 Cardifix Implantable Pacing Lead is explicitly labeled as a single-use device. It is supplied sterile and intended for one-time surgical implantation, after which it should not be reused.

• What are the key details about the regulatory pathway for this device, including its clearance status and classification?

  The Model 435-02 was cleared under FDA 510(k) (K862276) as a Class III medical device in 1986, classified under product code DTB (Permanent Pacemaker Electrode). It was determined substantially equivalent to a predicate device by the FDA’s Cardiovascular (CV) Advisory Committee, following a traditional review process.

• How is the Model 435-02 Cardifix Implantable Pacing Lead supplied, and what should clinicians consider during storage?

  The device is supplied as a sterile, pre-connected lead, ready for surgical implantation without additional preparation. Since it is single-use, clinicians should store it in its original packaging in a clean, dry environment, away from direct sunlight or extreme temperatures, to preserve sterility and functionality until use.

• Are there any known restrictions or considerations regarding MRI compatibility for this device?

  The provided data does not mention any MRI safety restrictions for the Model 435-02. However, clinicians should always verify compatibility with their specific MRI system and follow manufacturer guidelines, as pacemaker leads may interact with magnetic fields in unpredictable ways.