Clearance Summary
MEDI-TECH PLATFORM GUIDE CATHETER received FDA 510(k) clearance under submission number K952345, sponsored by Medi-Tech, 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 1995-08-17.
- Submission: K952345
- Applicant / Sponsor: Medi-Tech, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1250
- Decision date: 1995-08-17
Classification & Regulation
This clearance is catalogued under FDA product code DQY and 21 CFR 870.1250, within the Cardiovascular review panel as a Class II device.