Submission Details
| 510(k) Number | K182110 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 06, 2018 |
| Decision Date | November 02, 2018 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
CDI Blood Parameter Monitoring System 550
Nov 2018
Decision
88d
Days
Class 2
Risk
About This 510(k) Submission
K182110 is an FDA 510(k) clearance for the CDI Blood Parameter Monitoring System 550, 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 November 2, 2018, 88 days after receiving the submission on August 6, 2018. 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
Bryan K. Hann
29 submissions
29 cleared
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