SOLCART B— 510(k) K102194

Substantially Equivalent

B. Braun Avitum AG

FDA 510(k) clearance K102194 for SOLCART B, Substantially Equivalent on 2011-04-25. Applicant: B. Braun Avitum AG.

Clearance details

Applicant: B. Braun Avitum AG
Product code: Code KPO
Advisory panel: Gastroenterology, Urology
Date received: 2010-08-04
Decision date: 2011-04-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Allentown, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KPO

product code KPO

Death: 14
Malfunction: 775
Other: 20
Total: 809

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.