Medical Device Manufacturer · US , Eden Prairie , MN

Acist Medical Systems - FDA 510(k) Cleared Devices

7 submissions · 7 cleared · Since 1999

Recent clearances: CARDIOVASCULAR PRESSURE MEASUREMENT (CPM) SYSTEM, NAVVUS CATHETER, ACIST GENTOO CONTRAST INJECTION SYSTEM, ACIST PLUS 4 ANGIOGRAPHIC CATHETER

View 7 510(k) Devices ↓

7

Total

7

Cleared

0

Denied

FDA 510(k) Regulatory Record - Acist Medical Systems Cardiovascular ✕

7 devices

1-7 of 7

Cleared Jan 30, 2014

CARDIOVASCULAR PRESSURE MEASUREMENT (CPM) SYSTEM, NAVVUS CATHETER

Cardiovascular · 176d

Cleared Jan 27, 2003

ACIST GENTOO CONTRAST INJECTION SYSTEM

Cardiovascular · 314d

Cleared Apr 26, 2002

ACIST PLUS 4 ANGIOGRAPHIC CATHETER

Cardiovascular · 28d

Cleared May 31, 2000

MODIFICATION TO ACIST CL 100H

Cardiovascular · 426d

Cleared Mar 28, 2000

ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL R-2000

Cardiovascular · 85d

Cleared Dec 07, 1999

ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CL1OOH

Cardiovascular · 29d

Cleared Feb 11, 1999

ACIST INJECTOR SYSTEM, MODEL CL100 H

Cardiovascular · 90d