ARTERIAL & VENOUS BLOOD TUBING SETS FOR HEMODIALYSIS— 510(k) K934803

Substantially Equivalent

Baxter Healthcare Corp

FDA 510(k) clearance K934803 for ARTERIAL & VENOUS BLOOD TUBING SETS FOR HEMODIALYSIS, Substantially Equivalent on 1993-12-17. Applicant: Baxter Healthcare Corp.

Clearance details

Applicant: Baxter Healthcare Corp
Product code: Code FJK
Advisory panel: Gastroenterology, Urology
Date received: 1993-10-20
Decision date: 1993-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mcgaw Park, IL, 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.