Model 366-13 Adaptaid Step Down Adapter

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K864326 ↗

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 is the primary purpose of the Model 366-13 Adaptaid Step Down Adapter in a cardiac electrophysiology setting?

  The Model 366-13 Adaptaid Step Down Adapter is designed as an intermediary connector to resolve size or connector mismatches between pacemaker leads and pulse generators. Its main function is to reduce electrical impedance mismatch, ensuring proper pacing functionality and maintaining signal integrity within the pacemaker system.

• Is the Model 366-13 Adaptaid Step Down Adapter intended for single-use or can it be reused?

  The Model 366-13 is explicitly supplied as a reusable medical device. Since it is not sterile, it requires cleaning and sterilization between uses to maintain safety and functionality.

• How is the regulatory status of this device determined, and what does that mean for its use?

  The device received FDA clearance through a 510(k) submission (K864326) and is classified as substantially equivalent to prior-generation products. This means it adheres to regulatory standards for cardiovascular devices (regulation number 870.3680) and has been evaluated by the FDA’s Cardiovascular (CV) advisory committee for safety and performance.

• What types of pacemaker systems is this adapter compatible with, and how does it improve performance?

  The Model 366-13 is intended for use in cardiac electrophysiology procedures where pacemaker leads and pulse generators have size or connector mismatches. It improves performance by adapting the electrical output of the system, reducing impedance mismatch to ensure reliable pacing and signal integrity.