Model 366-30 Adaptaid Adapter Sleeve

No FDA recalls on record, checked 22 Oct 2026.

Full name

Model 366-30 Adaptaid(Tm) Adapter Sleeve

510(k) Number

K873921 ↗

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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See all devices from Intermedics, Inc. →

• What is the primary purpose of the Model 366-30 Adaptaid Adapter Sleeve in pacemaker systems?

  The Model 366-30 Adaptaid Adapter Sleeve acts as an intermediary connector between pacemaker leads and their respective pacing systems. It ensures secure electrical coupling and accommodates variations in lead and device interfaces, which helps maintain compatibility and reliable signal transmission during cardiovascular pacing procedures.

• Is the Model 366-30 Adaptaid Adapter Sleeve intended for single-use or reusable applications?

  The Model 366-30 Adaptaid Adapter Sleeve is designed for single-use in sterile cardiac procedures, though it is supplied as a reusable component for healthcare professionals to integrate into pacemaker lead systems. Sterility and proper handling protocols must be followed during use.

• Which pacemaker lead models is the Model 366-30 Adaptaid Adapter Sleeve validated for compatibility with?

  The adapter sleeve is validated for use with multiple pacemaker lead models, as referenced by the listed FEI numbers (e.g., 3002618605, 1028232, etc.) in the regulatory data. These identifiers correspond to specific lead types approved for integration with this adapter in cardiovascular pacing applications.

• How should the Model 366-30 Adaptaid Adapter Sleeve be stored and handled?

  The adapter sleeve must be stored and handled according to sterile medical device protocols, as it is intended for use in sterile cardiac procedures. Proper storage ensures its integrity and compliance with clinical standards for pacemaker components.

• What regulatory pathway was followed for FDA clearance of the Model 366-30 Adaptaid Adapter Sleeve?

  The Model 366-30 Adaptaid Adapter Sleeve received FDA 510(k) clearance under the Cardiovascular advisory committee, classified as a Class III device (regulation 870.3680). The submission was determined to be *substantially equivalent* (SESE) to a predicate device, following a traditional review process.