ASAHI REXEED-SX/LX SERIES DIALYZER— 510(k) K121409

Substantially Equivalent

Asahi Kasei Medical Co., Ltd.

FDA 510(k) clearance K121409 for ASAHI REXEED-SX/LX SERIES DIALYZER, Substantially Equivalent on 2013-02-06. Applicant: Asahi Kasei Medical Co., Ltd..

Clearance details

Applicant: Asahi Kasei Medical Co., Ltd.
Product code: Code KDI
Advisory panel: Gastroenterology, Urology
Date received: 2012-05-11
Decision date: 2013-02-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Charlestown, NH, 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.