Clearance Summary
EMBOSPHERE MICROSPHERES AND EMBOGOLD MICROSPHERES FOR USE IN UTERINE FIBROID EMBOLIZATION received FDA 510(k) clearance under submission number K021397, sponsored by Biosphere Medical, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2002-11-22.
- Submission: K021397
- Applicant / Sponsor: Biosphere Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.3300
- Decision date: 2002-11-22
Classification & Regulation
This clearance is catalogued under FDA product code NAJ and 21 CFR 870.3300, within the Cardiovascular review panel as a Class II device.