PORT ACCESS INFUSION SET— 510(k) K921901

Substantially Equivalent

Kawasumi Laboratories Co., Ltd.

FDA 510(k) clearance K921901 for PORT ACCESS INFUSION SET, Substantially Equivalent on 1993-09-10. Applicant: Kawasumi Laboratories Co., Ltd..

Clearance details

Applicant: Kawasumi Laboratories Co., Ltd.
Product code: Code FRN
Advisory panel: General Hospital
Date received: 1992-04-22
Decision date: 1993-09-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tokyo, JP

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Adverse events under product code FRN

product code FRN

Death: 540
Injury: 6,178
Malfunction: 1,464,165
Other: 52
Total: 1,470,935

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.