Blood Administration Set— 510(k) K210335

Name: FDA 510(k) clearance K210335
Creator: U.S. Food and Drug Administration
Published: 2021-06-10

Substantially Equivalent

Baxter Healthcare Corporation

FDA 510(k) clearance K210335 for Blood Administration Set, Substantially Equivalent on 2021-06-10. Applicant: Baxter Healthcare Corporation. Device class: 2.

Clearance details

Applicant: Baxter Healthcare Corporation
Product code: Code BRZ
Device class: Class 2
Regulation: 21 CFR 880.5440
Advisory panel: General Hospital
Date received: 2021-02-05
Decision date: 2021-06-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Round Lake, IL, US

Download summary PDF View on FDA.gov ↗

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K220558 — Blood Administration Sets2022-11-17
K132905 — 200 MICRON BLOOD COMPONENT FILTER AND SYRINGE ADAPTER2013-10-04
K083349 — BLOOD TRANSFUSION SET2009-04-10
K073339 — BLOOD COMPONENT RECIPIENT SET WITH STANDARD SIZE FILTER AND INFUSION SET WITH SIDE ARM LUER CONNECTOR2008-03-03
K041496 — PENTATRASFU BLOOD TRANSFUSION SETS2005-06-30

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Adverse events under product code BRZ

product code BRZ

Malfunction: 458
Total: 458

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.