Coaxial Bipolar Pacing Electrode

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K822239 ↗

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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• What types of cardiac procedures is this coaxial bipolar pacing electrode designed for, and how is it used in those settings?

  This device is specifically designed for cardiac rhythm management procedures requiring precise electrical pacing. It is intended for direct implantation in patients who need temporary or permanent cardiac pacing support, such as those with bradycardia or other conduction disorders. The coaxial bipolar configuration ensures stable and accurate impulse transmission to the heart, making it suitable for use with external pacemaker pulse generators during or after implantation.

• Is this pacing electrode single-use or reusable, and how should it be stored before use?

  The coaxial bipolar pacing electrode is supplied as a sterile, single-use device, meaning it is intended for one-time clinical application only. It comes in sterile packaging for immediate use, so storage should be kept in a clean, dry environment away from direct sunlight or extreme temperatures until ready for deployment. Always follow manufacturer guidelines for packaging integrity to ensure sterility is maintained.

• What regulatory pathway was followed for this device’s approval, and what class does it fall under?

  This device was cleared through the FDA 510(k) pathway under the traditional review process, with a decision classification of *Substantially Equivalent* (SESE). It is classified as a Class 3 medical device under FDA regulation 870.3680, reflecting its role in life-sustaining or life-supporting functions. The clearance number is K822239, and it was reviewed by the Cardiovascular (CV) Advisory Committee.

• How is this electrode compatible with other medical devices, and what should clinicians verify before use?

  The coaxial bipolar pacing electrode is designed to be compatible with external pacemaker pulse generators for delivering electrical pacing stimuli. Clinicians should verify compatibility with their specific pulse generator model to ensure proper function and safety. Since it is single-use and sterile, no additional sterilization or reprocessing is required—only proper handling and adherence to sterile technique during implantation.