Model 366-10 Adaptaid Step-Down Adapter

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K861110 ↗

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 366-10 Adaptaid Step-Down Adapter in pacemaker systems?

  The Model 366-10 Adaptaid Step-Down Adapter is designed to create a reliable electrical connection between pacemaker leads and pulse generators. Its role is to ensure proper signal transmission and compatibility, reducing the risk of electrical mismatches or damage during implantation or when replacing pacemaker components. This intermediary device helps maintain system integrity in cardiovascular surgical settings.

• Is the Model 366-10 Adaptaid Step-Down Adapter intended for single-use or reusable applications?

  The Model 366-10 Adaptaid Step-Down Adapter is explicitly supplied as a single-use component. While it is non-sterile as shipped, it must be handled to maintain sterility before use in surgical procedures, as improper handling could compromise its integrity for a single, controlled application.

• How should the Model 366-10 be stored to ensure it remains suitable for use?

  The adapter is non-sterile as supplied, so storage conditions focus on protecting it from contamination and physical damage. Since it is intended for single-use in cardiovascular surgical settings, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Follow the manufacturer’s instructions for proper packaging and handling to preserve its functionality until use.

• What regulatory pathway was followed for FDA clearance of this device, and what class does it belong to?

  The Model 366-10 Adaptaid Step-Down Adapter was cleared through the FDA 510(k) process under the traditional review pathway, with a decision of *Substantially Equivalent* (SESE). It is classified as a Class III medical device under FDA regulations (870.3680), which requires compliance with stringent manufacturing and performance standards due to its role in cardiovascular systems.