Clearance Summary
CBMYOTHERM XP CARDIOPLEGIA DELIVERY SYSTEM WITH CARMEDA BIOACTIVE SURFACE, MODELS CB41 AND CB41-B received FDA 510(k) clearance under submission number K003724, sponsored by Medtronic Vascular. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2000-12-21.
- Submission: K003724
- Applicant / Sponsor: Medtronic Vascular
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4240
- Decision date: 2000-12-21
Classification & Regulation
This clearance is catalogued under FDA product code DTR and 21 CFR 870.4240, within the Cardiovascular review panel as a Class II device.