EXCELARREST FOAM— 510(k) K072900

Substantially Equivalent

Hemostasis, LLC

FDA 510(k) clearance K072900 for EXCELARREST FOAM, Substantially Equivalent on 2007-10-26. Applicant: Hemostasis, LLC.

Clearance details

Applicant: Hemostasis, LLC
Product code: Code QSY
Advisory panel: Unknown
Date received: 2007-10-11
Decision date: 2007-10-26
Decision: Substantially Equivalent
Clearance type: Special
Location: St. Paul, MN, 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.