Product code SEQ

Device name

Covered Stent Vascular Connector, Hemodialysis Access Circuit

Medical specialty

Unknown

Device class

3

Review panel

CV

Implant

Y

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset