INTERVENTIONAL HEMOSTATIC BANDAGE— 510(k) K120782

Substantially Equivalent

Z-Medica Corporation

FDA 510(k) clearance K120782 for INTERVENTIONAL HEMOSTATIC BANDAGE, Substantially Equivalent on 2013-03-20. Applicant: Z-Medica Corporation.

Clearance details

Applicant: Z-Medica Corporation
Product code: Code QSY
Advisory panel: Unknown
Date received: 2012-03-15
Decision date: 2013-03-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wallingford, CT, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code QSY

product code QSY

Death: 5
Other: 1
Total: 6

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.