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

FDA 510(k) cleared devices by Acist Medical Systems, Inc. Cardiovascular ✕

12 devices

1-12 of 12

Cleared Jul 17, 2024

ACIST RXi System (016616)

Cardiovascular · 219d

Cleared Mar 20, 2020

ACIST HDi System, ACIST Kodama Intravascular Ultrasound Catheter

Cardiovascular · 123d

Cleared Sep 13, 2019

ACIST RXi System and Navvus II Catheter

Cardiovascular · 198d

Cleared Jun 27, 2019

ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System

Cardiovascular · 57d

Cleared Feb 16, 2018

ACISTCVi® Contrast Delivery System

Cardiovascular · 256d

Cleared Oct 23, 2017

ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System

Cardiovascular · 24d

Cleared Aug 18, 2017

ACIST RXi Mini System

Cardiovascular · 25d

Cleared Jan 15, 2010

ADAGIO RETRACTING ECG LEAD WIRES

Cardiovascular · 51d

Cleared Dec 16, 2005

C2000 AUTOMATED MANIFOLD KIT

Cardiovascular · 77d

Cleared Mar 15, 2004

ACIST ANTIOGRAPHIC INJECTION SYSTEM CONTRAST MANAGEMENT DISPOSABLE KITS

Cardiovascular · 35d

Cleared Mar 13, 2002

ACIST 4 FRENCH ANGIOGRAPHIC CATHETER

Cardiovascular · 189d

Cleared Mar 09, 2001

ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL R2000-CMS

Cardiovascular · 28d