Model 366-19 Adaptaid Adapter Sleeve

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K860985 ↗

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 366-19 Adaptaid Adapter Sleeve in a pacemaker system?

  The Model 366-19 Adaptaid Adapter Sleeve is designed to securely connect pacemaker leads and electrodes, ensuring reliable electrical conduction within pacemaker systems. This helps maintain proper function and performance of the implanted device by facilitating a stable interface between components.

• Is the Model 366-19 Adaptaid Adapter Sleeve intended for reuse or single-use in clinical settings?

  The Model 366-19 is explicitly intended for single-use in clinical settings, as stated in its description. This ensures sterility and reduces the risk of contamination or device failure from repeated use.

• How is the Model 366-19 Adaptaid Adapter Sleeve supplied, and what does that mean for handling?

  The device is supplied sterile, meaning it is pre-packaged and ready for immediate clinical use without additional sterilization. This ensures safety and compliance with infection control protocols, but users must follow manufacturer guidelines to maintain sterility until first use.

• What regulatory pathway was used for FDA clearance of this device, and what does that imply about its oversight?

  The Model 366-19 was cleared through the FDA 510(k) pathway in 1986 under product code DTB (Permanent Pacemaker Electrode) and classified as a Class III device. This classification indicates it is subject to stringent regulatory controls due to its role in life-sustaining or supporting cardiovascular procedures, ensuring high safety and performance standards.

• Are there multiple sizes or models of this adapter sleeve, or is it a standardized single design?

  The provided data does not specify multiple sizes or models for the Model 366-19 Adaptaid Adapter Sleeve, implying it is likely a standardized, single-design adapter. For compatibility with specific pacemaker leads or electrodes, users should verify with the manufacturer or device documentation, as variations may exist in related products.