Model 366-12 Adaptaid Step-Down Adapter

No FDA recalls on record, checked 22 Oct 2026.

Full name

Model 366-12 Adaptaid (Tm) Step-Down Adapter

510(k) Number

K871625 ↗

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 366-12 Adaptaid Step-Down Adapter in clinical settings?

  The Model 366-12 Adaptaid Step-Down Adapter is designed as a connector interface to ensure electrical compatibility between pacemaker leads and pulse generators. Its role is to reduce impedance mismatch, which helps maintain reliable signal transmission and proper pacing functionality during cardiovascular procedures like pacemaker implantation or lead revisions.

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

  This device is explicitly labeled as reusable and is intended for use in the operating room or electrophysiology lab. However, it is not sterile as supplied, so it must be cleaned and sterilized according to the manufacturer’s guidelines before reuse in subsequent procedures.

• What type of regulatory clearance does the Model 366-12 Adaptaid Step-Down Adapter hold, and under what classification?

  The device holds FDA 510(k) clearance under the classification of a Permanent Pacemaker Electrode, with the product code DTB. It was determined to be substantially equivalent to a predicate device and was reviewed by the Cardiovascular (CV) Advisory Committee in 1987.

• Are there any specific storage or handling instructions mentioned for this device?

  The device is not sterile and must be cleaned and sterilized prior to reuse. While no specific storage instructions are detailed in the provided data, standard medical device handling practices—such as protecting it from contamination and mechanical damage—should be followed to ensure its functionality and safety for repeated use.