K242276
- 510(k) number
- K242276
- Device name
- CrossFAST Integrated Microcatheter Guide Extension System (CFM55)
- Applicant
- Vantis Vascular, Inc. CA · US
- Product code
- DQY — Catheter, Percutaneous
- Decision date
- 2024-09-30
- Date received
- 2024-08-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K242276.pdf
Official FDA record: K242276
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.