Model 366-28 Adaptaid Step-Down Adapter

No FDA recalls on record, checked 22 Oct 2026.

Full name

Model 366-28 Adaptaid(Tm) Step-Down Adapter

510(k) Number

K864047 ↗

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 366-28 AdaptaID™ Step-Down Adapter in medical procedures?

  The Model 366-28 AdaptaID™ Step-Down Adapter is designed as a reusable intermediary connector to ensure compatibility between components in vascular intervention systems. It specifically facilitates proper alignment and function during procedures involving inferior vena cava (IVC) filters, acting as a bridge between system parts to maintain procedural integrity.

• Is the Model 366-28 AdaptaID™ Step-Down Adapter intended for single-use or reusable applications?

  The Model 366-28 AdaptaID™ Step-Down Adapter is explicitly supplied as a reusable medical device. This classification means it is engineered for repeated use in cardiovascular interventions, provided proper cleaning and maintenance protocols are followed.

• How is the regulatory status of this device determined, and what does that mean for its use?

  The Model 366-28 AdaptaID™ Step-Down Adapter holds FDA 510(k) clearance under the classification of a Class III device (regulation number 870.3680) and falls under product code DTB. This means it has been deemed substantially equivalent to a legally marketed predicate device through a traditional review process by the FDA, ensuring it meets established safety and effectiveness standards for use in cardiovascular interventions.

• What type of medical specialty is this device primarily associated with, and why?

  This device is primarily associated with the cardiovascular specialty. The Model 366-28 AdaptaID™ Step-Down Adapter is specifically designed to support procedures involving vascular interventions, such as those involving inferior vena cava (IVC) filters, which are critical components in cardiovascular care.