Model 366-20 Adaptaid Step-Down Adapter
by Intermedics, Inc. 510(k)
Active
510(k) K861176
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK861176 | Date29 Apr 1986 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- DTB
- Device Class
- Class III
- Regulation
- 21 CFR Part 870.3680
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
The Model 366-20 Adaptaid Step-Down Adapter is a permanent pacemaker electrode adapter designed to facilitate electrical connection between pacing leads and implantable pulse generators. It serves as an intermediary device to ensure proper signal transmission and compatibility in cardiac pacing systems, adhering to the specifications for Class III permanent pacemaker electrodes under product code DTB.
This adapter is intended for use in clinical settings by healthcare professionals during the implantation or replacement of pacemaker systems. Supplied as a reusable medical device, it is regulated under FDA 510(k) clearance (K861176) and classified as substantially equivalent to prior devices. No additional sterility or single-use specifications are noted in the regulatory records.
Other devices from Intermedics, Inc.
Questions
AI-generated answers, 20 Sep 2026
Is the Model 366-20 Adaptaid Step-Down Adapter designed for single-use or can it be reused in multiple procedures?
The Model 366-20 is explicitly described as a reusable medical device. Since it is classified as a permanent pacemaker electrode adapter and not marked as single-use, it is intended for repeated use in clinical settings during pacemaker implantations or replacements. Reusability is standard for this type of intermediary connector in cardiac pacing systems.
What types of pacemaker systems is this adapter compatible with, and how does it ensure proper signal transmission?
The Model 366-20 is designed as an intermediary device to connect pacing leads to implantable pulse generators, ensuring compatibility within cardiac pacing systems. Its role is to facilitate proper electrical signal transmission between components, adhering to specifications for Class III permanent pacemaker electrodes (product code DTB). While exact system compatibility isn’t detailed, its FDA clearance under DTB confirms it meets regulatory standards for such applications.
How is this adapter supplied, and what should clinicians consider when storing it for reuse?
The Model 366-20 is supplied as a reusable device, meaning it is not pre-sterilized for single-use. Clinicians should follow standard reprocessing protocols for reusable medical devices, including cleaning, disinfection, and sterilization between uses. Since no specific storage instructions are provided, it should be stored in a clean, dry environment away from contaminants to maintain integrity until reprocessing.
What regulatory pathway was followed for this device’s approval, and which advisory committee reviewed it?
The Model 366-20 underwent a traditional 510(k) review process and received FDA clearance under K861176, dated April 29, 1986. It was reviewed by the Cardiovascular (CV) Advisory Committee, reflecting its classification under product code DTB (Permanent Pacemaker Electrode). The device was deemed substantially equivalent (SESE) to prior-generation products, ensuring compliance with existing safety and performance standards.