CARDIOHELP SYSTEM
FDA 510(k) clearance K133598 · decided 2014-05-21
Clearance details
- K-number
- K133598
- Device name
- CARDIOHELP SYSTEM
- Applicant
- Maquet Cardiopulmonary, AG
- Decision
- Substantially Equivalent
- Date received
- 2013-11-22
- Decision date
- 2014-05-21
- Days to decision
- 180 days
- Clearance type
- Traditional
- Product code
- DTQ
- Device class
- 2
- Regulation number
- 870.4220
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Wayne, NJ, US
- Third-party review
- No
- Expedited review
- No
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