PERI-GUARD PERICARDIAL PATCH— 510(k) K842066

Substantially Equivalent

Genetic Laboratories, Inc.

FDA 510(k) clearance K842066 for PERI-GUARD PERICARDIAL PATCH, Substantially Equivalent on 1985-12-30. Applicant: Genetic Laboratories, Inc..

Clearance details

Applicant: Genetic Laboratories, Inc.
Product code: 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

Download summary PDF View on FDA.gov ↗

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.