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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
510(k) Number K234065
Device Name CDI OneView Monitoring System
Applicant
Terumo Cardiovascular Systems Corporation
6200 Jackson Rd.
Ann Arbor,  MI  48103
Applicant Contact Rahul Reddy Chinkeri
Correspondent
Terumo Cardiovascular Systems Corporation
6200 Jackson Rd.
Ann Arbor,  MI  48103
Correspondent Contact Rahul Reddy Chinkeri
Regulation Number870.4330
Classification Product Code
DRY  
Date Received12/22/2023
Decision Date 04/25/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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