Clearance Summary
iSLEEVE Introducer Set received FDA 510(k) clearance under submission number K180785, sponsored by Boston Scientific Corporation. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2018-06-22.
- Submission: K180785
- Applicant / Sponsor: Boston Scientific Corporation
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1340
- Decision date: 2018-06-22
Classification & Regulation
This clearance is catalogued under FDA product code DYB and 21 CFR 870.1340, within the Cardiovascular review panel as a Class II device.