Device typeVascular-grafting anastomosis system: An assembly of sterile devices designed to create an opening between a blood vessel and a vascular graft (native or synthetic) during a vascular surgical procedure [e.g., coronary artery bypass grafting (CABG), or arteriovenous fistula (AVF) grafting]. It typically includes a delivery tool loaded with metallic clips/connectors/couplers (e.g., surgical stainless steel). A blood vessel graft is loaded into the delivery tool, and upon manual actuation of the tool, the fastening devices are deployed through the graft and into the target vessel, and the tool creates an opening in the target vessel (e.g., aortotomy, arteriotomy). This is a single-use device.
FDA categorySurgical Kit
Device IDM602801H00013
Catalog number801-H.00.01
AvailabilityPrescription
Single useYes
SterileYes
MRI safetyMR Conditional