Submission Details
| 510(k) Number | K133598 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 22, 2013 |
| Decision Date | May 21, 2014 |
| Days to Decision | 180 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
CARDIOHELP SYSTEM
May 2014
Decision
180d
Days
Class 2
Risk
About This 510(k) Submission
K133598 is an FDA 510(k) clearance for the CARDIOHELP SYSTEM, a Console, Heart-lung Machine, Cardiopulmonary Bypass (Class II — Special Controls, product code DTQ), submitted by Maquet Cardiopulmonary, AG (Wayne, US). The FDA issued a Cleared decision on May 21, 2014, 180 days after receiving the submission on November 22, 2013. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4220.
Device Classification
| Product Code | DTQ — Console, Heart-lung Machine, Cardiopulmonary Bypass |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.4220 |
Manufacturer
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