Medical Device Manufacturer · US , Eden Prairie , MN

Acist Medical Systems, Inc. - FDA 510(k) Cleared Devices

14 submissions · 14 cleared · Since 2001
14
Total
14
Cleared
0
Denied

Acist Medical Systems, Inc. has 14 FDA 510(k) cleared cardiovascular devices. Based in Eden Prairie, US.

Latest FDA clearance: Jul 2024. 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.

FDA 510(k) Regulatory Record - Acist Medical Systems, Inc.
14 devices
1-14 of 14
Cleared Jul 17, 2024
ACIST RXi System (016616)
K233904 · DXO
Cardiovascular · 219d
Cleared Dec 17, 2020
ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System
K203004 · DXT
General Hospital · 77d
Cleared Mar 20, 2020
ACIST HDi System, ACIST Kodama Intravascular Ultrasound Catheter
K193183 · OBJ
Cardiovascular · 123d
Cleared Sep 13, 2019
ACIST RXi System and Navvus II Catheter
K190473 · OBI
Cardiovascular · 198d
Cleared Jul 18, 2019
ACIST CVI1 Contrast Delivery System, A1000 Syringe Kit, A1000V Syringe Kit,...
K191060 · DXT
General Hospital · 87d
Cleared Jun 27, 2019
ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System
K191175 · OBJ
Cardiovascular · 57d
Cleared Feb 16, 2018
ACISTCVi® Contrast Delivery System
K171646 · DXT
Cardiovascular · 256d
Cleared Oct 23, 2017
ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System
K173063 · OBJ
Cardiovascular · 24d
Cleared Aug 18, 2017
ACIST RXi Mini System
K172216 · DRQ
Cardiovascular · 25d
Cleared Jan 15, 2010
ADAGIO RETRACTING ECG LEAD WIRES
K093657 · DSA
Cardiovascular · 51d
Cleared Dec 16, 2005
C2000 AUTOMATED MANIFOLD KIT
K052744 · DXT
Cardiovascular · 77d
Cleared Mar 15, 2004
ACIST ANTIOGRAPHIC INJECTION SYSTEM CONTRAST MANAGEMENT DISPOSABLE KITS
K040298 · DXT
Cardiovascular · 35d
Cleared Mar 13, 2002
ACIST 4 FRENCH ANGIOGRAPHIC CATHETER
K012983 · DQO
Cardiovascular · 189d
Cleared Mar 09, 2001
ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL R2000-CMS
K010390 · DXT
Cardiovascular · 28d
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