Clearance Summary
BALADI INVERTER WITH COAXIAL AORTIC PUNCH received FDA 510(k) clearance under submission number K980128, sponsored by Cardio Medical Solutions, 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 1998-07-24.
- Submission: K980128
- Applicant / Sponsor: Cardio Medical Solutions, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4450
- Decision date: 1998-07-24
Classification & Regulation
This clearance is catalogued under FDA product code DXC and 21 CFR 870.4450, within the Cardiovascular review panel as a Class II device.