K842066

Substantially Equivalent

PERI-GUARD PERICARDIAL PATCH

Applicant: Genetic Laboratories, Inc.
Product code: DXZ
Advisory panel: Cardiovascular
Date received: 1984-04-23
Decision date: 1985-12-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Paul, MN, US

Adverse events under product code DXZ

product code DXZ

Death: 19
Injury: 265
Total: 284

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.