Clearance Summary
Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter received FDA 510(k) clearance under submission number K150046, sponsored by Zoll Circulation, 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 2015-10-30.
- Submission: K150046
- Applicant / Sponsor: Zoll Circulation, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.5900
- Decision date: 2015-10-30
Classification & Regulation
This clearance is catalogued under FDA product code NCX and 21 CFR 870.5900, within the Cardiovascular review panel as a Class II device.