K233736
- 510(k) number
- K233736
- Device name
- LifeSPARC System
- Applicant
- Cardiacassist, Inc. PA · US
- Product code
- QNR — Blood Pump For Ecmo, Long-Term (> 6 Hours) Use
- Decision date
- 2024-01-19
- Date received
- 2023-11-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 1.4 MB · U.S. public domain
Also available from FDA: K233736.pdf
Official FDA record: K233736
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.