Clearance Summary
LIFEBRIDGE B2T, MODEL 7001 received FDA 510(k) clearance under submission number K090006, sponsored by Lifebridge Medizintechnik 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 2009-10-15.
- Submission: K090006
- Applicant / Sponsor: Lifebridge Medizintechnik AG
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4220
- Decision date: 2009-10-15
Classification & Regulation
This clearance is catalogued under FDA product code DTQ and 21 CFR 870.4220, within the Cardiovascular review panel as a Class II device.