K233647
- 510(k) number
- K233647
- Device name
- VersaCross Connect Transseptal Dilator
- Applicant
- Baylis Medical Company, Inc. CA
- Product code
- DRE — Dilator, Vessel, For Percutaneous Catheterization
- Decision date
- 2023-12-14
- Date received
- 2023-11-14
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K233647.pdf
Official FDA record: K233647
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.