Clearance Summary
TIP DEFLECTOR (GENESIS) received FDA 510(k) clearance under submission number K943257, sponsored by Electro-Catheter Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1995-04-19.
- Submission: K943257
- Applicant / Sponsor: Electro-Catheter Corp.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1220
- Decision date: 1995-04-19
Classification & Regulation
This clearance is catalogued under FDA product code DRF and 21 CFR 870.1220, within the Cardiovascular review panel as a Class II device.