200 MICRON BLOOD COMPONENT FILTER AND SYRINGE ADAPTER— 510(k) K132905

Name: FDA 510(k) clearance K132905
Creator: U.S. Food and Drug Administration
Published: 2013-10-04

Substantially Equivalent

Arteriocyte Medical Systems, Inc.

FDA 510(k) clearance K132905 for 200 MICRON BLOOD COMPONENT FILTER AND SYRINGE ADAPTER, Substantially Equivalent on 2013-10-04. Applicant: Arteriocyte Medical Systems, Inc.. Device class: 2.

Clearance details

Applicant: Arteriocyte Medical Systems, Inc.
Product code: Code BRZ
Device class: Class 2
Regulation: 21 CFR 880.5440
Advisory panel: General Hospital
Date received: 2013-09-16
Decision date: 2013-10-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hopkinton, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code BRZ

view all

K220558 — Blood Administration Sets2022-11-17
K210335 — Blood Administration Set2021-06-10
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

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.