GUARDIVA ANTIMICROBIAL HAEMSTATIC IV DRESSING— 510(k) K121485

Substantially Equivalent

Hemcon Medical Technologies Europe, Ltd.

FDA 510(k) clearance K121485 for GUARDIVA ANTIMICROBIAL HAEMSTATIC IV DRESSING, Substantially Equivalent on 2012-08-21. Applicant: Hemcon Medical Technologies Europe, Ltd..

Clearance details

Applicant: Hemcon Medical Technologies Europe, Ltd.
Product code: Code QSY
Advisory panel: Unknown
Date received: 2012-05-18
Decision date: 2012-08-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Portland, OR, 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.