Model 435-01 Cardifix Implantable Pacing Lead

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K854917 ↗

FDA Product Code

DTB

Device Class

Class III

Regulation

21 CFR Part 870.3680

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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See all devices from Intermedics, Inc. →

• What is the primary purpose of the Model 435-01 Cardifix Implantable Pacing Lead, and where is it typically implanted in the body?

  The Model 435-01 Cardifix Implantable Pacing Lead is designed to deliver electrical stimulation to the heart for patients with bradycardia or conduction disorders. It is intended for transvenous implantation, meaning it is inserted through a vein and positioned in either the right atrium or right ventricle to restore normal heart rhythms when integrated with an implantable pulse generator.

• Is this device intended for single-use or reusable applications, and what handling precautions should be taken during use?

  The Model 435-01 is a single-use device and must be handled under aseptic conditions to ensure sterility. It is intended for sterile surgical implantation by qualified healthcare professionals in controlled environments like a cardiac catheterization lab or operating room. Proper storage and handling prior to use are critical to maintain its integrity.

• What regulatory pathway was followed for FDA clearance of this device, and what classification does it fall under?

  The Model 435-01 received FDA 510(k) clearance under the Cardiovascular advisory committee via a Traditional 510(k) review, with a decision classification of Substantially Equivalent. It is classified as a Device Class III under regulation number 870.3680, indicating it requires stringent oversight due to its role in life-sustaining or life-supporting functions.

• Are there any specific storage instructions provided for this device before implantation?

  While the provided data does not detail exact storage conditions, the device is sterile and single-use, so it must be stored according to the manufacturer’s instructions (Intermedics, Inc.) to preserve sterility and functionality. This typically includes protection from contamination, extreme temperatures, and physical damage until use in a clinical setting.