Clearance Summary
CONVOY ADVANCED DELIVERY SHEATH KIT received FDA 510(k) clearance under submission number K013866, sponsored by Boston Scientific. The device was reviewed via the Special premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2001-12-14.
- Submission: K013866
- Applicant / Sponsor: Boston Scientific
- Clearance pathway: Special
- Review panel: Immunology
- Device class: Class I
- Regulation citation: 21 CFR 866.5520
- Decision date: 2001-12-14
Classification & Regulation
This clearance is catalogued under FDA product code DBY and 21 CFR 866.5520, within the Immunology review panel as a Class I device.