Model 366-27 Adaptaid Step-Down Adapter

No FDA recalls on record, checked 22 Oct 2026.

Full name

Model 366-27 Adaptaid(Tm) Step-Down Adapter

510(k) Number

K864048 ↗

FDA Product Code

DTB

Device Class

Class III

Regulation

21 CFR Part 870.3680

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Lifeline Unipolar Lead #487-05

  Class III

  FDA 510(k) K823508 Active Cleared 14 Jan 1983

• Implant Aid Splicing Crimp & Sleeve

  Class III

  FDA 510(k) K813518 Active Cleared 12 Jan 1982

• Veri-Vu Lensometer

  Class I

  FDA 510(k) K791521 Active Cleared 30 Oct 1979

• Implantable Pulse Generator Pacemakers

  Class III

  FDA 510(k) K791568 Active Cleared 19 Sep 1979

• Model 480-01 Pacing Lead

  Class III

  FDA 510(k) K844270 Active Cleared 28 Mar 1985

• GE Lead Adapter, Model 345-01

  Class II

  FDA 510(k) K801040 Active Cleared 30 Jun 1980

See all devices from Intermedics, Inc. →

• What is the primary purpose of the Model 366-27 Adaptaid Step-Down Adapter in pacemaker systems?

  The Model 366-27 Adaptaid Step-Down Adapter is designed as a permanent pacemaker electrode device to create a reliable electrical connection between pacing leads and implantable pulse generators. Its role is to ensure proper signal transmission and compatibility within pacemaker systems, acting as an intermediary to maintain optimal performance.

• Is this device intended for single-use or can it be reused in multiple procedures?

  The Model 366-27 Adaptaid Step-Down Adapter is explicitly supplied as a reusable medical instrument. It is engineered for durability and repeated use in cardiovascular procedures, provided it is properly cleaned and maintained according to manufacturer guidelines.

• How was this device’s regulatory pathway determined, and what classification does it hold?

  The Model 366-27 was cleared through the Traditional 510(k) pathway in 1986 and is classified as a Class 3 device under FDA product code DTB for permanent pacemaker electrodes. Its regulatory classification reflects its role in ensuring critical electrical connectivity in cardiovascular applications, requiring stringent compliance with 870.3680 regulations.

• What medical specialty is primarily associated with the use of this device?

  The Model 366-27 Adaptaid Step-Down Adapter is categorized under Cardiovascular medical specialty, aligning with its intended use in pacemaker systems for patients requiring electrical signal management in heart rhythm therapies.