Clearance Summary
THERMODILUTION CATHETER received FDA 510(k) clearance under submission number K083384, sponsored by Biosensors Intl. Pte. , Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2010-01-05.
- Submission: K083384
- Applicant / Sponsor: Biosensors Intl. Pte. , Ltd.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1200
- Decision date: 2010-01-05
Classification & Regulation
This clearance is catalogued under FDA product code DQO and 21 CFR 870.1200, within the Cardiovascular review panel as a Class II device.