K233503
- 510(k) number
- K233503
- Device name
- 14F iSLEEVE Introducer Set
- Applicant
- Boston Scientific Corporation MN · US
- Product code
- DYB — Introducer, Catheter
- Decision date
- 2023-11-30
- Date received
- 2023-10-31
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
510(k) Summary (official FDA PDF): K233503.pdf
Official FDA record: K233503
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.