ARTERIAL BLOOD TUBING SET FOR SINGLE NEEDLE HEMODIALYSIS— 510(k) K955277

Substantially Equivalent

Baxter Healthcare Corp

FDA 510(k) clearance K955277 for ARTERIAL BLOOD TUBING SET FOR SINGLE NEEDLE HEMODIALYSIS, Substantially Equivalent on 1996-02-16. Applicant: Baxter Healthcare Corp.

Clearance details

Applicant: Baxter Healthcare Corp
Product code: Code KOC
Advisory panel: Gastroenterology, Urology
Date received: 1995-11-17
Decision date: 1996-02-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mcgaw Park, IL, US

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Adverse events under product code KOC

product code KOC

Death: 4
Total: 4

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.