Submission Details
| 510(k) Number | K234065 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 22, 2023 |
| Decision Date | April 25, 2024 |
| Days to Decision | 125 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
CDI OneView Monitoring System
Apr 2024
Decision
125d
Days
Class 2
Risk
About This 510(k) Submission
K234065 is an FDA 510(k) clearance for the CDI OneView Monitoring System, a Monitor, Blood-gas, On-line, Cardiopulmonary Bypass (Class II — Special Controls, product code DRY), submitted by Terumo Cardiovascular Systems Corporation (Ann Arbor, US). The FDA issued a Cleared decision on April 25, 2024, 125 days after receiving the submission on December 22, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4330.
Device Classification
| Product Code | DRY — Monitor, Blood-gas, On-line, Cardiopulmonary Bypass |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.4330 |
Manufacturer
Terumo Cardiovascular Systems Corporation
Ann Arbor, MI · US
Rahul Reddy Chinkeri
29 submissions
29 cleared
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