Acist Medical Systems, Inc. is one of 16052 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Acist Medical Systems, Inc. - FDA 510(k) Cleared Devices
Recent clearances: VueJect® Ultrasound Enhancing Agent Delivery System, VeraPro S100 Multi-Use Syringe (018808), ACIST Pro Diagnostic System (019304)
17
Total
17
Cleared
0
Denied
Acist Medical Systems, Inc. has 17 FDA 510(k) cleared cardiovascular devices. Based in Eden Prairie, US.
Latest FDA clearance: Aug 2026. Active since 2001.
Browse the complete list of FDA 510(k) cleared cardiovascular devices from this manufacturer. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Regulatory Technology Services, LLC as regulatory consultant.
FDA 510(k) Regulatory Record - Acist Medical Systems, Inc.
17 devices
Cleared
Aug 03, 2026
VueJect® Ultrasound Enhancing Agent Delivery System
General Hospital
41d
Cleared
May 13, 2026
VeraPro S100 Multi-Use Syringe (018808)
General Hospital
266d
Cleared
May 13, 2026
ACIST Pro Diagnostic System (019304)
General Hospital
264d
Cleared
Jul 17, 2024
ACIST RXi System (016616)
Cardiovascular
219d
Cleared
Dec 17, 2020
ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System
General Hospital
77d
Cleared
Mar 20, 2020
ACIST HDi System, ACIST Kodama Intravascular Ultrasound Catheter
Cardiovascular
123d
Cleared
Sep 13, 2019
ACIST RXi System and Navvus II Catheter
Cardiovascular
198d
Cleared
Jul 18, 2019
ACIST CVI1 Contrast Delivery System, A1000 Syringe Kit, A1000V Syringe Kit,...
General Hospital
87d
Cleared
Jun 27, 2019
ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System
Cardiovascular
57d
Cleared
Feb 16, 2018
ACISTCVi® Contrast Delivery System
Cardiovascular
256d
Cleared
Oct 23, 2017
ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System
Cardiovascular
24d
Cleared
Aug 18, 2017
ACIST RXi Mini System
Cardiovascular
25d