CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, CentriMag Drainage (Venous) Cannula Kit— 510(k) K200306

Name: FDA 510(k) clearance K200306
Creator: U.S. Food and Drug Administration
Published: 2020-03-06

Substantially Equivalent

Abbott (Formerly Thoratec Corporation)

FDA 510(k) clearance K200306 for CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, CentriMag Drainage (Venous) Cannula Kit, Substantially Equivalent on 2020-03-06. Applicant: Abbott (Formerly Thoratec Corporation). Device class: 2.

Clearance details

Applicant: Abbott (Formerly Thoratec Corporation)
Product code: Code DWA
Device class: Class 2
Regulation: 21 CFR 870.4380
Advisory panel: Cardiovascular
Date received: 2020-02-06
Decision date: 2020-03-06
Decision: Substantially Equivalent
Clearance type: Special
Location: Pleasanton, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code DWA

product code DWA

Death: 15
Malfunction: 1,654
Total: 1,669

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.