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ACIST Medical Systems, Inc.

17 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
VueJect® Ultrasound Enhancing Agent Delivery System (K262115)ACIST Medical Systems, Inc.2026-08-03
ACIST Pro Diagnostic System (019304); Processing Unit Bed Mount; AngioTouch Module; ACIST Pro Cart; Single Transducer Cable; Triple Transducer Cable (K252653)Acist Medical Systems, Inc.2026-05-13
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) (K252638)Acist Medical Systems, Inc.2026-05-13
ACIST RXi System (016616); ACIST Navvus II Catheter (016675_ (K233904)Acist Medical Systems, Inc.2024-07-17
ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System (K203004)Acist Medical Systems, Inc.2020-12-17
ACIST HDi System, ACIST Kodama Intravascular Ultrasound Catheter (K193183)Acist Medical Systems, Inc.2020-03-20
ACIST RXi System and Navvus II Catheter (K190473)Acist Medical Systems, Inc.2019-09-13
ACIST CVI1 Contrast Delivery System, A1000 Syringe Kit, A1000V Syringe Kit, BT2000 Manifold Kit, BT2000 Manifold Kit, AngioToiuch Hand Controller Kit (K191060)Acist Medical Systems, Inc.2019-07-18
ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System (K191175)Acist Medical Systems, Inc.2019-06-27
ACISTCVi® Contrast Delivery System (K171646)Acist Medical Systems, Inc.2018-02-16
ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System (K173063)Acist Medical Systems, Inc.2017-10-23
ACIST RXi Mini System (K172216)Acist Medical Systems, Inc.2017-08-18
ADAGIO RETRACTING ECG LEAD WIRES (K093657)Acist Medical Systems, Inc.2010-01-15
C2000 AUTOMATED MANIFOLD KIT (K052744)Acist Medical Systems, Inc.2005-12-16
ACIST ANTIOGRAPHIC INJECTION SYSTEM CONTRAST MANAGEMENT DISPOSABLE KITS (K040298)Acist Medical Systems, Inc.2004-03-15
ACIST 4 FRENCH ANGIOGRAPHIC CATHETER (K012983)Acist Medical Systems, Inc.2002-03-13
ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL R2000-CMS (K010390)Acist Medical Systems, Inc.2001-03-09

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Every clearance here is in the API, with alerts when new ones post.