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ACIST Medical Systems, Inc. FDA Approvals
0 new drug approvals and 4 device clearances on file. This applicant is not matched to a listed company.
Newest first
A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.
| Product |
|---|
| VueJect® Ultrasound Enhancing Agent Delivery System510(k)Aug 3, 2026Cardiovascular |
| ACIST Pro Diagnostic System (019304); Processing Unit Bed Mount; AngioTouch Module; ACIST Pro Cart; Single Transducer Cable; Triple Transducer Cable510(k)May 13, 2026Cardiovascular |
| VeraPro S100 Multi-Use Syringe (018808); VeraPro S100 LV1 Low Viscosity Single-Use Syringe (018811); VeraPro AMT Auto-Manifold and Transducer (018814); VeraPro AngioTouch FLX165 Hand Controller Kit (018806); VeraPro AngioTouch HiFi165 Hand Controller Kit (018804)510(k)May 13, 2026Cardiovascular |
| ACIST RXi System (016616); ACIST Navvus II Catheter (016675_510(k)Jul 17, 2024Cardiovascular |