K250542
- 510(k) number
- K250542
- Device name
- AC3 Range Intra-Aortic Balloon Pump
- Applicant
- Arrow International, LLC NC · US
- Product code
- DSP — System, Balloon, Intra-Aortic And Control
- Decision date
- 2025-03-26
- Date received
- 2025-02-24
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K250542.pdf
Official FDA record: K250542
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.