510(k) clearance
CrossFAST Integrated Microcatheter Advanced Delivery System
- 510(k) number
- K262817
- Applicant
- Vantis Vascular, Inc.
- Decision date
- Sep 18, 2026
- Date received
- Aug 7, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Product code
- DQY
- Device type
- Catheter, Percutaneous
- Device class
- Class II
- Regulation
- 21 CFR 870.1250
- Advisory committee
- Cardiovascular
- Statement or summary
- Summary
- Third party
- N
- Location
- San Jose, CA, US