K232852
- 510(k) number
- K232852
- Device name
- Cross Vascular RF Transseptal Needle, Cross Vascular Connection Cable
- Applicant
- Cross Vascular, Inc. CA · US
- Product code
- DXF — Catheter, Septostomy
- Decision date
- 2023-10-12
- Date received
- 2023-09-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Flag
- Third-party review
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K232852.pdf
Official FDA record: K232852
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.