CARDIOHELP SYSTEM
FDA 510(k) clearance K102726 · decided 2011-04-04
Clearance details
- K-number
- K102726
- Device name
- CARDIOHELP SYSTEM
- Applicant
- Maquet Cardiopulmonary, AG
- Decision
- Substantially Equivalent
- Date received
- 2010-09-21
- Decision date
- 2011-04-04
- Days to decision
- 195 days
- Clearance type
- Traditional
- Product code
- DTQ
- Device class
- 2
- Regulation number
- 870.4220
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Hirrlingen, DE
- Third-party review
- No
- Expedited review
- No
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