CAVH/CVVH/CAVHD SET MODEL #HT-HF/505— 510(k) K921597

Substantially Equivalent

Haemotronic, Inc.

FDA 510(k) clearance K921597 for CAVH/CVVH/CAVHD SET MODEL #HT-HF/505, Substantially Equivalent on 1995-02-24. Applicant: Haemotronic, Inc..

Clearance details

Applicant: Haemotronic, Inc.
Product code: Code FJK
Advisory panel: Gastroenterology, Urology
Date received: 1992-04-03
Decision date: 1995-02-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fairfield, NJ, US

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Adverse events under product code FJK

product code FJK

Death: 52
Malfunction: 3,430
Total: 3,482

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.