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

K874930 ↗

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 366-12 Adaptaid Step-Down Adapter in cardiovascular procedures?

  The Model 366-12 Adaptaid Step-Down Adapter is designed as an intermediary connector to bridge the size difference between larger-diameter pacemaker leads and smaller-diameter pacemaker electrodes. This ensures compatibility during implantation or adjustments, allowing for smoother transitions in cardiovascular procedures.

• Is the Model 366-12 Adaptaid Step-Down Adapter intended for single-use or reusable applications?

  The device is explicitly labeled for single-use in sterile environments, despite being supplied as a reusable adapter in sterile packaging. This distinction is critical for infection control and procedural safety, as it aligns with FDA guidance for Class III cardiovascular devices.

• How is the Model 366-12 Adaptaid Step-Down Adapter packaged and prepared for use?

  The adapter is supplied in sterile packaging, ensuring it meets the aseptic requirements for cardiovascular implantation procedures. The sterile barrier prevents contamination before use, which is essential for minimizing infection risks during pacemaker-related interventions.

• What regulatory pathway does the Model 366-12 Adaptaid Step-Down Adapter follow, and how does it relate to its classification?

  The device follows the FDA 510(k) clearance pathway (K874930) under Class III classification (product code DTB) for permanent pacemaker electrodes. Its clearance was determined through a traditional 510(k) review by the Cardiovascular (CV) Advisory Committee, with a decision of *Substantially Equivalent* (SESE) to a predicate device, ensuring compliance with stringent cardiovascular device regulations.