ScleroSafe 150 mm, ScleroSafe 350 mm— 510(k) K231148

Substantially Equivalent

Vvt Medical , Ltd.

FDA 510(k) clearance K231148 for ScleroSafe 150 mm, ScleroSafe 350 mm, Substantially Equivalent on 2023-06-20. Applicant: Vvt Medical , Ltd..

Clearance details

Applicant: Vvt Medical , Ltd.
Product code: Code KRA
Advisory panel: Cardiovascular
Date received: 2023-04-21
Decision date: 2023-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kfar Saba, IL

Download summary PDF View on FDA.gov ↗

Adverse events under product code KRA

product code KRA

Death: 234
Injury: 1,029
Malfunction: 3,012
Other: 2
Total: 4,277

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.