Model 438-01 Cardifix Implantable Pacing Lead

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K862052 ↗

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 438-01 Cardifix Implantable Pacing Lead, and how is it used in clinical practice?

  The Model 438-01 Cardifix Implantable Pacing Lead is designed to deliver electrical stimulation to the heart for patients with bradycardia or conduction disorders, ensuring consistent pacing via its fixed electrode configuration. It is intended for transvenous implantation—meaning it is inserted through a vein—by a healthcare professional in a sterile operating environment. This lead helps regulate cardiac rhythm by providing reliable pacing support.

• Is the Model 438-01 Cardifix Implantable Pacing Lead reusable, or is it meant for single-use only?

  The Model 438-01 Cardifix Implantable Pacing Lead is supplied sterile and intended for single-use only. It is not designed for reuse, as this could compromise sterility and patient safety. Each lead is meant to be implanted once in a controlled surgical setting.

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

  The Model 438-01 Cardifix Implantable Pacing Lead was cleared under the traditional review pathway by the FDA via a 510(k) submission (K862052). It is classified as a Class III device, which is the highest regulatory classification for medical devices requiring strict oversight due to its role in life-sustaining or life-supporting functions, such as cardiac pacing.

• What compliance standards does this device adhere to, particularly regarding cardiovascular implant requirements?

  The Model 438-01 adheres to FDA regulation 870.3680, which establishes compliance standards for cardiovascular implant devices. This regulation ensures that the lead meets specific performance, safety, and labeling requirements for transvenous pacing leads, including design, testing, and manufacturing controls.

• How should the Model 438-01 Cardifix Implantable Pacing Lead be stored before use, given its sterile packaging?

  Since the Model 438-01 is supplied sterile and single-use, it should be stored in its original, unopened packaging in a clean, dry environment away from direct sunlight or extreme temperatures. The packaging should remain intact until immediately before use to maintain sterility, as opening or exposing it prematurely could compromise its sterile condition.