HEMOHALT HEMOSTASIS PAD— 510(k) K060409

Substantially Equivalent

Vanson-Halosource, Inc.

FDA 510(k) clearance K060409 for HEMOHALT HEMOSTASIS PAD, Substantially Equivalent on 2006-05-17. Applicant: Vanson-Halosource, Inc..

Clearance details

Applicant: Vanson-Halosource, Inc.
Product code: Code QSY
Advisory panel: Unknown
Date received: 2006-02-16
Decision date: 2006-05-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redmond, WA, US

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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.