OMNI-STAT Vascular (Rapid); CELOX Vascular Rapid— 510(k) K190012

Substantially Equivalent

Medtrade Product, Ltd.

FDA 510(k) clearance K190012 for OMNI-STAT Vascular (Rapid); CELOX Vascular Rapid, Substantially Equivalent on 2019-12-18. Applicant: Medtrade Product, Ltd..

Clearance details

Applicant: Medtrade Product, Ltd.
Product code: Code QSY
Advisory panel: Unknown
Date received: 2019-01-03
Decision date: 2019-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Crewe, GB

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.