CentriMag Acute Circulatory Support System— 510(k) K234118

Name: FDA 510(k) clearance K234118
Creator: U.S. Food and Drug Administration
Published: 2024-01-26

Substantially Equivalent

ABBOTT MEDICAL

FDA 510(k) clearance K234118 for CentriMag Acute Circulatory Support System, Substantially Equivalent on 2024-01-26. Applicant: ABBOTT MEDICAL. Device class: 2.

Clearance details

Applicant: ABBOTT MEDICAL
Product code: Code QNR
Device class: Class 2
Regulation: 21 CFR 870.4100
Advisory panel: Cardiovascular
Date received: 2023-12-28
Decision date: 2024-01-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Pleasanton, CA, US

Download summary PDF View on FDA.gov ↗

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K222038 — CentriMag Blood Pump for use with CentriMag Acute Circulatory Support System2022-12-08

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Adverse events under product code QNR

product code QNR

Death: 11
Total: 11

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.