Clearance Summary
BMC COAXIAL INJECTABLE CATHETER, MODEL CIC 38/145 AND CIC 35/145 received FDA 510(k) clearance under submission number K014075, sponsored by Baylis Medical Co., 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 2002-03-07.
- Submission: K014075
- Applicant / Sponsor: Baylis Medical Co., Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1330
- Decision date: 2002-03-07
Classification & Regulation
This clearance is catalogued under FDA product code DQX and 21 CFR 870.1330, within the Cardiovascular review panel as a Class II device.