CLO-SURPLUS P.A.D.— 510(k) K092552

Substantially Equivalent

Scion Cardio-Vascular, Inc.

FDA 510(k) clearance K092552 for CLO-SURPLUS P.A.D., Substantially Equivalent on 2009-09-04. Applicant: Scion Cardio-Vascular, Inc..

Clearance details

Applicant: Scion Cardio-Vascular, Inc.
Product code: Code QSY
Advisory panel: Unknown
Date received: 2009-08-20
Decision date: 2009-09-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, 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.