Vascette HP (hemostatic pad)— 510(k) K220566

Substantially Equivalent

Koag, LLC

FDA 510(k) clearance K220566 for Vascette HP (hemostatic pad), Substantially Equivalent on 2022-07-29. Applicant: Koag, LLC.

Clearance details

Applicant: Koag, LLC
Product code: Code QSY
Advisory panel: Unknown
Date received: 2022-02-28
Decision date: 2022-07-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vonore, TN, 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.