Clearance Summary
MODEL 3100 SERIES SHEATH INTRODUCER KITS, MODELS 3110, 3130 received FDA 510(k) clearance under submission number K040552, sponsored by Cryocor, 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 2004-05-28.
- Submission: K040552
- Applicant / Sponsor: Cryocor, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1340
- Decision date: 2004-05-28
Classification & Regulation
This clearance is catalogued under FDA product code DYB and 21 CFR 870.1340, within the Cardiovascular review panel as a Class II device.