Cardifix Endocardial Pacing Lead

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K922042 ↗

FDA Product Code

DTB

Device Class

Class III

Regulation

21 CFR Part 870.3680

Advisory Committee

Cardiovascular

FDA Decision

SESP Substantially Equivalent — Postmarket Surveillance

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See all devices from Intermedics, Inc. →

• What is the Cardifix Endocardial Pacing Lead used for in clinical practice?

  The Cardifix Endocardial Pacing Lead is designed for endocardial placement within the heart to deliver electrical stimulation for cardiac pacing. It helps synchronize heart chamber contractions, addressing conditions like bradycardia or conduction disorders by transmitting pacing impulses directly to the myocardial tissue.

• Is the Cardifix Endocardial Pacing Lead intended for single-use or reusable applications?

  The Cardifix Endocardial Pacing Lead is explicitly supplied sterile and intended for single-use only. This ensures patient safety and adheres to regulatory standards for Class III medical devices.

• How should the Cardifix Endocardial Pacing Lead be stored before use?

  While the provided data does not specify exact storage conditions, the lead is supplied sterile, so it must be stored in its original, unopened packaging to maintain sterility until immediately before use. Always follow manufacturer guidelines for handling and storage.

• Can this device be used in patients who require MRI scans?

  Yes, the Cardifix Endocardial Pacing Lead is compatible with MRI environments under defined conditions. However, the specific MRI safety parameters (e.g., magnetic field strength, imaging sequences) must be reviewed and followed as outlined in the device’s technical specifications to ensure patient safety.

• What regulatory pathway was followed for FDA clearance of this device?

  The Cardifix Endocardial Pacing Lead received FDA 510(k) clearance (K922042) under the traditional review pathway, classified as a Class III device. The submission was reviewed by the FDA’s Cardiovascular (CV) Advisory Committee, and the decision was made under the Special Emergency Submission Procedure (SESP) in 1993.