Clearance Summary
HYPERFORM OCCLUSION BALLOON SYSTEM, MODEL 104-4470, 104-4471, 104-4770, 104-4771 received FDA 510(k) clearance under submission number K011656, sponsored by Micro Therapeutics, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2001-06-20.
- Submission: K011656
- Applicant / Sponsor: Micro Therapeutics, Inc.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4450
- Decision date: 2001-06-20
Classification & Regulation
This clearance is catalogued under FDA product code MJN and 21 CFR 870.4450, within the Cardiovascular review panel as a Class II device.