HEMOCONCENTRATOR— 510(k) K123288

Substantially Equivalent

Maquet Cardiopulmonary, AG

FDA 510(k) clearance K123288 for HEMOCONCENTRATOR, Substantially Equivalent on 2013-06-26. Applicant: Maquet Cardiopulmonary, AG.

Clearance details

Applicant: Maquet Cardiopulmonary, AG
Product code: Code KDI
Advisory panel: Gastroenterology, Urology
Date received: 2012-10-22
Decision date: 2013-06-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rastatt De-Bw, DE

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.