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

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..

Clearance details

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

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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.