K240600
- 510(k) number
- K240600
- Device name
- SafeCross Vascular Introducer System (4001)
- Applicant
- East End Medical I, LLC FL · US
- Product code
- DYB — Introducer, Catheter
- Decision date
- 2024-09-06
- Date received
- 2024-03-04
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K240600.pdf
Official FDA record: K240600
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.