DIALOG WITH ADIMEA OPTION— 510(k) K083460

Substantially Equivalent

B. Braun Avitum AG

FDA 510(k) clearance K083460 for DIALOG WITH ADIMEA OPTION, Substantially Equivalent on 2010-02-18. Applicant: B. Braun Avitum AG.

Clearance details

Applicant: B. Braun Avitum AG
Product code: Code KDI
Advisory panel: Gastroenterology, Urology
Date received: 2008-11-21
Decision date: 2010-02-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Allentown, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KDI

product code KDI

Death: 352
Injury: 1,474
Malfunction: 12,534
Other: 4
Total: 14,364

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.