K172637

Substantially Equivalent

HeRO Graft

Applicant: Merit Medical Systems, Inc.
Product code: DSY
Advisory panel: Cardiovascular
Date received: 2017-09-01
Decision date: 2017-11-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South Jordan, UT, US

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.