K234118
- 510(k) number
- K234118
- Device name
- CentriMag Acute Circulatory Support System
- Applicant
- ABBOTT MEDICAL CA · US
- Product code
- QNR — Blood Pump For Ecmo, Long-Term (> 6 Hours) Use
- Decision date
- 2024-01-26
- Date received
- 2023-12-28
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 1.3 MB · U.S. public domain
Also available from FDA: K234118.pdf
Official FDA record: K234118
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.