Clearance Summary
HEART-LIFT BALLOON POSITIONER received FDA 510(k) clearance under submission number K982419, sponsored by Cardiothoracic Systems, 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 1999-01-13.
- Submission: K982419
- Applicant / Sponsor: Cardiothoracic Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class I
- Regulation citation: 21 CFR 870.4500
- Decision date: 1999-01-13
Classification & Regulation
This clearance is catalogued under FDA product code MWS and 21 CFR 870.4500, within the Cardiovascular review panel as a Class I device.