Clearance Summary
FLEXCATH STEERABLE SHEATH & DILATOR, MODELS 3FC10, 3FC12 received FDA 510(k) clearance under submission number K081049, sponsored by Cryocath Technologies, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2008-06-27.
- Submission: K081049
- Applicant / Sponsor: Cryocath Technologies, Inc.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1280
- Decision date: 2008-06-27
Classification & Regulation
This clearance is catalogued under FDA product code DRA and 21 CFR 870.1280, within the Cardiovascular review panel as a Class II device.