Clearance Summary
ACIST HDi System, ACIST Kodama Intravascular Ultrasound Catheter received FDA 510(k) clearance under submission number K193183, sponsored by Acist Medical Systems, 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 2020-03-20.
- Submission: K193183
- Applicant / Sponsor: Acist Medical Systems, Inc.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1200
- Decision date: 2020-03-20
Classification & Regulation
This clearance is catalogued under FDA product code OBJ and 21 CFR 870.1200, within the Cardiovascular review panel as a Class II device.