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

Clearance details

Applicant

Baxter Healthcare Corp

Product code

Code KOC

Device class

Class 2

Regulation

21 CFR 876.5820

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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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 →