Clearance Summary
INITARY BETTER BLADDER-PEDIATRIC received FDA 510(k) clearance under submission number K140321, sponsored by Circulatory Technology, 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 2014-04-17.
- Submission: K140321
- Applicant / Sponsor: Circulatory Technology, Inc.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4400
- Decision date: 2014-04-17
Classification & Regulation
This clearance is catalogued under FDA product code DTN and 21 CFR 870.4400, within the Cardiovascular review panel as a Class II device.