VECTRA (TM) VASCULAR ACCESS GRAFT-5MM DIAMETER,6MM DIAMETER AND VECTRA (TM) VASCULAR ACCESS GRAFT FOR REVISION-5MM DIAME— 510(k) K001927

Substantially Equivalent

Thoratec Laboratories Corp.

FDA 510(k) clearance K001927 for VECTRA (TM) VASCULAR ACCESS GRAFT-5MM DIAMETER,6MM DIAMETER AND VECTRA (TM) VASCULAR ACCESS GRAFT FOR REVISION-5MM DIAME, Substantially Equivalent on 2000-12-18. Applicant: Thoratec Laboratories Corp..

Clearance details

Applicant: Thoratec Laboratories Corp.
Product code: Code DSY
Advisory panel: Cardiovascular
Date received: 2000-06-26
Decision date: 2000-12-18
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, 2020-01-01 through 2026-04-23. 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.