HEMODIALYSIS VENOUS BLOOD TUBING SET OR SIMILAR TRADE NAME— 510(k) K971687

Substantially Equivalent

National Medical Care, Inc.

FDA 510(k) clearance K971687 for HEMODIALYSIS VENOUS BLOOD TUBING SET OR SIMILAR TRADE NAME, Substantially Equivalent on 1997-07-29. Applicant: National Medical Care, Inc..

Clearance details

Applicant: National Medical Care, Inc.
Product code: Code FJK
Advisory panel: Gastroenterology, Urology
Date received: 1997-05-02
Decision date: 1997-07-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockleigh, 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.