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

Name: FDA 510(k) clearance K971687
Creator: U.S. Food and Drug Administration
Published: 1997-07-29

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.. Device class: 2.

Clearance details

Applicant: National Medical Care, Inc.
Product code: Code FJK
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 1997-05-02
Decision date: 1997-07-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockleigh, NJ, US

Download summary PDF View on FDA.gov ↗

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K971313 — NMC HEMODIALYSIS ARTERIAL BLOOD TUBING SET1997-10-27

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.