510(k) K193183
K193183 is an FDA 510(k) premarket notification submitted by Acist Medical Systems, Inc. for the device "ACIST HDi System, ACIST Kodama Intravascular Ultrasound Catheter". The FDA issued a decision of Substantially Equivalent on March 20, 2020. The device falls under product code OBJ (Catheter, Ultrasound, Intravascular), a Class II device regulated under 21 CFR 870.1200. Acist Medical Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 20, 2020
- Date Received
- November 18, 2019
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Ultrasound, Intravascular
- Device Class
- Class II
- Regulation Number
- 870.1200
- Review Panel
- CV
- Submission Type
For intracardiac and intraluminal visualization of cardiovascular anatomy and physiology.