SEQ — Covered Stent Vascular Connector, Hemodialysis Access Circuit Class III

FDA Device Classification

FDA product code SEQ covers "Covered Stent Vascular Connector, Hemodialysis Access Circuit", a Class III medical device. Submissions are reviewed by the Unknown panel. Devices under this code are implants.

Classification Details

Product Code
SEQ
Device Class
Class III
Regulation Number
Submission Type
Review Panel
CV
Medical Specialty
Unknown
Implant
Yes

Definition

The device is intended for suture-less attachment between an arteriovenous (AV) graft to a native vessel or between two native vessels (i.e., lack of suture placement on one or both ends) for the creation of a hemodialysis access site.