Clearance Summary
SLEEK OTW PTA CATHETERS received FDA 510(k) clearance under submission number K102035, sponsored by ClearStream Technologies , Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2010-12-01.
- Submission: K102035
- Applicant / Sponsor: ClearStream Technologies , Ltd.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1250
- Decision date: 2010-12-01
Classification & Regulation
This clearance is catalogued under FDA product code LIT and 21 CFR 870.1250, within the Cardiovascular review panel as a Class II device.