Clearance Summary
VENOUS BUBBLE TRAP, MODEL VBT 160; VENOUS BUBBLE TRAP WITH BIOLINE COATING, MODEL BE-VBT 160, BEQ-VBT 160 received FDA 510(k) clearance under submission number K082412, sponsored by Mapquet Cardiopulmonary AG. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2008-11-10.
- Submission: K082412
- Applicant / Sponsor: Mapquet Cardiopulmonary AG
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4230
- Decision date: 2008-11-10
Classification & Regulation
This clearance is catalogued under FDA product code DTP and 21 CFR 870.4230, within the Cardiovascular review panel as a Class II device.