Clearance Summary
QUANTIX/OR BLOOD FLOW MONITOR; FLEXIBLE PROBE WITH OPTIONAL VESSEL STABILIZER received FDA 510(k) clearance under submission number K050088, sponsored by Neoprobe Corp.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2005-02-08.
- Submission: K050088
- Applicant / Sponsor: Neoprobe Corp.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2100
- Decision date: 2005-02-08
Classification & Regulation
This clearance is catalogued under FDA product code DPW and 21 CFR 870.2100, within the Cardiovascular review panel as a Class II device.