LEVITRONIX CENTRIMAG PRIMARY CONSOLE, THORATEC CENTRIMAG PRIMARY CONSOLE— 510(k) K081221

Name: FDA 510(k) clearance K081221
Creator: U.S. Food and Drug Administration
Published: 2008-06-19

Substantially Equivalent

Levitronix, LLC

FDA 510(k) clearance K081221 for LEVITRONIX CENTRIMAG PRIMARY CONSOLE, THORATEC CENTRIMAG PRIMARY CONSOLE, Substantially Equivalent on 2008-06-19. Applicant: Levitronix, LLC. Device class: 2.

Clearance details

Applicant: Levitronix, LLC
Product code: Code DWA
Device class: Class 2
Regulation: 21 CFR 870.4380
Advisory panel: Cardiovascular
Date received: 2008-04-30
Decision date: 2008-06-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waltham, MA, US

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K093832 — LEVITRONIX CENTRIMAG PRIMARY AND BACKUP CONSOLES2010-01-13
K090051 — LEVITRONIX PEDIMAG BLOOD PUMP, MODEL 201-900522009-10-08

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.