510(k) K190473
K190473 is an FDA 510(k) premarket notification submitted by Acist Medical Systems, Inc. for the device "ACIST RXi System and Navvus II Catheter". The FDA issued a decision of Substantially Equivalent on September 13, 2019. The device falls under product code OBI (Catheter, Pressure Monitoring, Cardiac), 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
- September 13, 2019
- Date Received
- February 27, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Pressure Monitoring, Cardiac
- Device Class
- Class II
- Regulation Number
- 870.1200
- Review Panel
- CV
- Submission Type
To measure pressure within the cardiovascular system.