Clearance Summary
AMMEX TUBING ORGANIZER received FDA 510(k) clearance under submission number K934782, sponsored by Ammex Cardiopulmonary 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 1993-11-18.
- Submission: K934782
- Applicant / Sponsor: Ammex Cardiopulmonary Corp.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class I
- Regulation citation: 21 CFR 870.4200
- Decision date: 1993-11-18
Classification & Regulation
This clearance is catalogued under FDA product code KRI and 21 CFR 870.4200, within the Cardiovascular review panel as a Class I device.