DeviceClearance

K001927

Substantially Equivalent

VECTRA (TM) VASCULAR ACCESS GRAFT-5MM DIAMETER,6MM DIAMETER AND VECTRA (TM) VASCULAR ACCESS GRAFT FOR REVISION-5MM DIAME

Applicant
Thoratec Laboratories Corp.
Product code
DSY
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Pleasanton, CA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code DSY

product code DSY
Death
29
Injury
694
Total
723

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.