K251325
- 510(k) number
- K251325
- Device name
- VersaCross Connect Transseptal Dilator
- Applicant
- Baylis Medical Company, Inc. CA
- Product code
- DRE — Dilator, Vessel, For Percutaneous Catheterization
- Decision date
- 2025-05-29
- Date received
- 2025-04-29
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K251325.pdf
Official FDA record: K251325
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.