Model 366-09 Adaptaid Adapter Sleeve

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K860986 ↗

FDA Product Code

DTB

Device Class

Class III

Regulation

21 CFR Part 870.3680

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K813518 Active Cleared 12 Jan 1982

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  FDA 510(k) K801040 Active Cleared 30 Jun 1980

See all devices from Intermedics, Inc. →

• What is the primary purpose of the Model 366-09 Adaptaid Adapter Sleeve in a clinical setting?

  The Model 366-09 Adaptaid Adapter Sleeve acts as a permanent intermediary connector between pacemaker leads and implantable pulse generators. Its role is to ensure reliable electrical continuity and mechanical stability during pacemaker implantation, helping to maintain proper function of the cardiac device system.

• Is the Model 366-09 Adaptaid Adapter Sleeve intended for reuse, or is it designed for single-use only?

  The Model 366-09 Adaptaid Adapter Sleeve is explicitly designed for single-use in cardiovascular procedures. This aligns with standard sterile medical device protocols to prevent contamination and ensure patient safety.

• How should the Model 366-09 Adaptaid Adapter Sleeve be stored to maintain its sterility?

  Since the device is supplied sterile, it must be stored and handled according to sterile medical device protocols. This includes keeping it in its original packaging until immediate use and adhering to manufacturer guidelines to preserve sterility.

• What regulatory pathway was followed for FDA clearance of this device, and what classification does it hold?

  The Model 366-09 Adaptaid Adapter Sleeve received FDA 510(k) clearance (K860986) under the Traditional 510(k) review pathway, with a decision of Substantially Equivalent (SESE). It is classified as a Class 3 medical device under FDA product code DTB, reflecting its role in cardiovascular applications.