Terumo Cardiovascular Systems Corporation

Entity profile compiled from public source records

Public Record Profile Registrations: 0 510(k) filings: 1 Recalls: 2

Known Identifiers & Locations

FEI Numbers 1828100, 3000204839
Owner Operator Numbers N/A
Locations Covered N/A

Registered Establishments (0)

No device registration and listing records found for this entity.

510(k) Premarket Notifications (1)

Submission # Device Name Decision Date Decision Description Action
K234065 CDI OneView Monitoring System 2024-04-25 Substantially Equivalent View Details

FDA Recall History (2)

Recall # Product Description Initiation Date Status Action
Z-0001-2017 CDI H/S Cuvette The intended use for the CDI H IS Cuvette is as follows: The CDI H/S Cuvettes are intended for use with a CDI monitor during cardiopulmonary bypass procedures when continuous monitoring of blood hematocrit and oxygen saturation is desired. Reason: Terumo Cardiovascular Systems (Terumo CVS) has received complaints of the CDI System 500 monitor displaying the H/S DISCONNECT AT CUVETTE error message when the CDI H/S Cuvette does not make a proper connection to the CDI H/S Probe. In this situation, blood parameter values for HCT, Hgb, and SO2 do not display. 2015-12-11 Terminated View Details
Z-0024-2011 Air bubble detection cable assembly, catalog numbers 78-8067-7375-6 and 149892, Terumo Cardiovascular System, Ann Arbor, MI Reason: Malfunction of the air bubble detection cable assembly causes a false air alarm or a check sensor message during system set-up. In some instances, users were not able to reset the alarm to allow for further air bubble detection. . 2010-10-15 Terminated View Details

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