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ACIST Medical Systems, Inc.

FDA 510(k) & PMA Approved Devices — 17 products

Total Devices17
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K262115 VueJect® Ultrasound Enhancing Agent Delivery SystemIZQ2026-08-03 View
510(k) K252638 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)DXT2026-05-13 View
510(k) K252653 ACIST Pro Diagnostic System (019304); Processing Unit Bed Mount; AngioTouch Module; ACIST Pro Cart; Single Transducer Cable; Triple Transducer CableDXT2026-05-13 View
510(k) K233904 ACIST RXi System (016616); ACIST Navvus II Catheter (016675_DXO2024-07-17 View
510(k) K203004 ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery SystemDXT2020-12-17 View
510(k) K193183 ACIST HDi System, ACIST Kodama Intravascular Ultrasound CatheterOBJ2020-03-20 View
510(k) K190473 ACIST RXi System and Navvus II CatheterOBI2019-09-13 View
510(k) K191060 ACIST CVI1 Contrast Delivery System, A1000 Syringe Kit, A1000V Syringe Kit, BT2000 Manifold Kit, BT2000 Manifold Kit, AngioToiuch Hand Controller KitDXT2019-07-18 View
510(k) K191175 ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi SystemOBJ2019-06-27 View
510(k) K171646 ACISTCVi® Contrast Delivery SystemDXT2018-02-16 View
510(k) K173063 ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi SystemOBJ2017-10-23 View
510(k) K172216 ACIST RXi Mini SystemDRQ2017-08-18 View
510(k) K093657 ADAGIO RETRACTING ECG LEAD WIRESDSA2010-01-15 View
510(k) K052744 C2000 AUTOMATED MANIFOLD KITDXT2005-12-16 View
510(k) K040298 ACIST ANTIOGRAPHIC INJECTION SYSTEM CONTRAST MANAGEMENT DISPOSABLE KITSDXT2004-03-15 View
510(k) K012983 ACIST 4 FRENCH ANGIOGRAPHIC CATHETERDQO2002-03-13 View
510(k) K010390 ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL R2000-CMSDXT2001-03-09 View
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