Medical Device Manufacturer · US , Sunnyvale , CA

Cardiovascular Imaging Systems, Inc. - FDA 510(k) Cleared Devices

19 submissions · 19 cleared · Since 1989

19

Total

19

Cleared

0

Denied

FDA 510(k) Regulatory Record - Cardiovascular Imaging Systems, Inc. Radiology ✕

11 devices

1-11 of 11

Cleared Jun 20, 1997

BSC, SONICATH ULTRA IMAGING CATHETER 3.2F/20MHZ(37410/456221 & BSC, SONICATH...

Radiology · 165d

Cleared Jul 21, 1993

CVIS INSIGHT IMAGING GUIDE CATHETER

Radiology · 183d

Cleared Jun 29, 1993

CVIS INSIGHT IMAGING CATHETER

Radiology · 330d

Cleared Jun 02, 1993

Radiology · 132d

Cleared Jul 13, 1992

CVIS INSIGHT III SYSTEM

Radiology · 91d

Cleared Jul 02, 1992

CVIS INSIGHT IMAGING CATHETER FOR INTRALUMINAL

Radiology · 87d

Cleared Jun 16, 1992

CVIS INSIGHT IMAGING CATHETER FOR INTRALUMINAL USE

Radiology · 97d

Cleared Jun 16, 1992

CVIS INSIGHT CATHETERS FOR INTRACARDIAC USE

Radiology · 97d

Cleared Sep 11, 1991

CVIS INSIGHT IMAGING CATHETERS

Radiology · 163d

Cleared Aug 22, 1989

CVIS ULTRA-SCAN ONE IMAGING CATHETER

Radiology · 90d

Cleared May 16, 1989

CVIS ULTRA-SCAN ONE IMAGING SYSTEM

Radiology · 68d