Clearance Summary
MILLENNIUM VALVE INTRODUCER/ROTATOR HANDLE received FDA 510(k) clearance under submission number K980016, sponsored by Genzyme Surgical Product (Genzyme Biosurgery). The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1998-08-07.
- Submission: K980016
- Applicant / Sponsor: Genzyme Surgical Product (Genzyme Biosurgery)
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class I
- Regulation citation: 21 CFR 870.3935
- Decision date: 1998-08-07
Classification & Regulation
This clearance is catalogued under FDA product code MOP and 21 CFR 870.3935, within the Cardiovascular review panel as a Class I device.