Clearance Summary
BAYLIS MEDICAL RF SEPTOSTOMY GENERATOR, NYKANEN RF SEPTOSTOMY CATHETER, BAYLIS MEDICAL CONNECTOR CABLE received FDA 510(k) clearance under submission number K990284, 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 2001-02-01.
- Submission: K990284
- Applicant / Sponsor: Baylis Medical Co., Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.5175
- Decision date: 2001-02-01
Classification & Regulation
This clearance is catalogued under FDA product code DXF and 21 CFR 870.5175, within the Cardiovascular review panel as a Class II device.