MODIFIED SEPACELL R-500 AND R-500A BLOOD FILTERS— 510(k) K896976

Substantially Equivalent

Asahi Medical Co., Ltd.

FDA 510(k) clearance K896976 for MODIFIED SEPACELL R-500 AND R-500A BLOOD FILTERS, Substantially Equivalent on 1990-01-24. Applicant: Asahi Medical Co., Ltd..

Clearance details

Applicant: Asahi Medical Co., Ltd.
Product code: Code CAK
Advisory panel: General Hospital
Date received: 1989-12-13
Decision date: 1990-01-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

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Adverse events under product code CAK

product code CAK

Malfunction: 476
Total: 476

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.