Clearance Summary
Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Start-Up Kit, Coolgard 3000 Console, Thermogard XP Console received FDA 510(k) clearance under submission number K213031, 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 2021-12-20.
- Submission: K213031
- Applicant / Sponsor: Zoll Circulation, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.5900
- Decision date: 2021-12-20
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.