Model 366-23 Adaptaid Step-Down Adapter
by Intermedics, Inc. 510(k)
Active
510(k) K864428
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK864428 | Date5 Dec 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- Withdrawn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
- Full name
- Model 366-23 Adaptaid(Tm) Step-Down Adapter
- 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, 18 Sep 2026
The Model 366-23 Adaptaid Step-Down Adapter is a Permanent Pacemaker Electrode, designed to facilitate electrical connection between a pacemaker pulse generator and an electrode lead. It serves as an intermediary device to ensure proper impedance matching and signal integrity in cardiac pacing applications, maintaining compatibility between different electrode systems and pulse generators.
This adapter is supplied as a reusable medical device, intended for use in clinical settings such as cardiac electrophysiology labs or operating rooms. It is classified as a Class III device under FDA regulations (21 CFR 870.3680) and holds a Traditional 510(k) clearance (K864428) with a decision of Substantially Equivalent to a predicate device. The adapter is not sterile and must be cleaned and sterilized between uses as per manufacturer guidelines.
Other devices from Intermedics, Inc.
Questions
AI-generated answers, 18 Sep 2026
What is the primary purpose of the Model 366-23 Adaptaid Step-Down Adapter in cardiac pacing procedures?
The Model 366-23 Adaptaid Step-Down Adapter is designed as an intermediary device to ensure proper electrical connection between a pacemaker pulse generator and an electrode lead. Its key function is to maintain impedance matching and signal integrity, which helps preserve compatibility between different electrode systems and pulse generators in cardiac pacing applications.
Is the Model 366-23 Adaptaid Step-Down Adapter intended for single-use or can it be reused?
The Model 366-23 is explicitly classified as a reusable medical device. Since it is not sterile as supplied, it must be cleaned and sterilized between uses according to the manufacturer’s guidelines, making it suitable for repeated use in clinical settings like cardiac electrophysiology labs or operating rooms.
What type of regulatory clearance does the Model 366-23 Adaptaid Step-Down Adapter hold, and how was it determined?
The Model 366-23 holds a Traditional 510(k) clearance (K864428) from the FDA, determined to be *Substantially Equivalent* to a predicate device. This classification falls under the Cardiovascular advisory committee (CV) and is categorized as a Class III device under FDA regulations (21 CFR 870.3680), reflecting its role in ensuring critical electrical performance in cardiac pacing.
Where would this adapter typically be used, and what clinical environments are most appropriate for it?
The Model 366-23 is intended for use in controlled clinical settings such as cardiac electrophysiology labs or operating rooms. Its reusable design and role in maintaining signal integrity make it suitable for environments where precise pacing adjustments are required, such as during pacemaker implantations, lead replacements, or troubleshooting pacing-related issues.