Clearance Summary
PROTECTOR INTRODUCER SHEATH received FDA 510(k) clearance under submission number K930808, sponsored by Boston Scientific /International Technologies. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1994-03-15.
- Submission: K930808
- Applicant / Sponsor: Boston Scientific /International Technologies
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1340
- Decision date: 1994-03-15
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.