Clearance Summary
S3 CARDIOPLEGIA CONTROL MODULE VERSION 2.0 received FDA 510(k) clearance under submission number K002116, sponsored by Medical Device Consultants, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2000-08-09.
- Submission: K002116
- Applicant / Sponsor: Medical Device Consultants, Inc.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4220
- Decision date: 2000-08-09
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.