Clearance Summary
COOL LINE CATHETER, MODEL CL-2295A, ICY CATHETER, MODEL IC-3893A AND QUATTRO CATHETER, MODEL IC-4593 received FDA 510(k) clearance under submission number K101987, sponsored by Zoll Circulation. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2010-10-12.
- Submission: K101987
- Applicant / Sponsor: Zoll Circulation
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.5900
- Decision date: 2010-10-12
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.