FDA 510(k) Applications Submitted by ACIST MEDICAL SYSTEMS, INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K052744 |
09/30/2005 |
C2000 AUTOMATED MANIFOLD KIT |
ACIST MEDICAL SYSTEMS, INC. |
| K093657 |
11/25/2009 |
ADAGIO RETRACTING ECG LEAD WIRES |
ACIST MEDICAL SYSTEMS, INC. |
| K172216 |
07/24/2017 |
ACIST RXi Mini System |
ACIST Medical Systems, Inc. |
| K173063 |
09/29/2017 |
ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System |
ACIST Medical Systems, Inc. |
| K191175 |
05/01/2019 |
ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System |
ACIST Medical Systems, Inc. |
| K193183 |
11/18/2019 |
ACIST HDi System, ACIST Kodama Intravascular Ultrasound Catheter |
ACIST Medical Systems, Inc. |
| K010390 |
02/09/2001 |
ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL R2000-CMS |
ACIST MEDICAL SYSTEMS, INC. |
| K040298 |
02/09/2004 |
ACIST ANTIOGRAPHIC INJECTION SYSTEM CONTRAST MANAGEMENT DISPOSABLE KITS |
ACIST MEDICAL SYSTEMS, INC. |
| K012983 |
09/05/2001 |
ACIST 4 FRENCH ANGIOGRAPHIC CATHETER |
ACIST MEDICAL SYSTEMS, INC. |
| K203004 |
10/01/2020 |
ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System |
ACIST Medical Systems, Inc. |
| K191060 |
04/22/2019 |
ACIST CVI1 Contrast Delivery System, A1000 Syringe Kit, A1000V Syringe Kit, BT2000 Manifold Kit, BT2000 Manifold Kit, AngioToiuch Hand Controller Kit |
ACIST Medical Systems, Inc. |
| K171646 |
06/05/2017 |
ACISTCVi« Contrast Delivery System |
ACIST Medical Systems, Inc. |
| K190473 |
02/27/2019 |
ACIST RXi System and Navvus II Catheter |
ACIST Medical Systems, Inc. |
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