CLO-SURPLUS P.A.D.— 510(k) K112961

Substantially Equivalent

Scion Cardio-Vascular, Inc.

FDA 510(k) clearance K112961 for CLO-SURPLUS P.A.D., Substantially Equivalent on 2011-10-31. Applicant: Scion Cardio-Vascular, Inc..

Clearance details

Applicant: Scion Cardio-Vascular, Inc.
Product code: Code QSY
Advisory panel: Unknown
Date received: 2011-10-04
Decision date: 2011-10-31
Decision: Substantially Equivalent
Clearance type: Special
Location: Melbourne, FL, 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.