Medical Device Manufacturer · US , Sunnyvale , CA

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

19 submissions · 19 cleared · Since 1989

Recent clearances: BSC, SONICATH ULTRA IMAGING CATHETER 3.2F/20MHZ(37410/456221 & BSC, SONICATH ULTRA IMAGING CATHETER 2.9F/20MHZ/37411/, MICROVIEW II/MICRORAIL II CATHETERS, AUTOMATIC PULL BACK DEVICE

19

Total

19

Cleared

0

Denied

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

8 devices

1-8 of 8

Cleared Aug 01, 1994

MICROVIEW II/MICRORAIL II CATHETERS

Cardiovascular · 87d

Cleared Oct 15, 1993

AUTOMATIC PULL BACK DEVICE

Cardiovascular · 87d

Cleared Jul 16, 1992

CBIS CATHETER PULL-BACK DEVICE

Cardiovascular · 87d

Cleared Apr 12, 1991

CVIS INSIGHT IMAGING CATHETER

Cardiovascular · 183d

Cleared Feb 21, 1991

CVIS INSIGHT IMAGING CATHETER

Cardiovascular · 69d

Cleared Jul 09, 1990

CVIS INSIGHT IMAGING CATHETER

Cardiovascular · 97d

Cleared Jul 06, 1990

CVIS INSIGHT 15MHZ CATHETERS FOR PERIPHERAL USE

Cardiovascular · 87d

Cleared Mar 26, 1990

CVIS INSIGHT IMAGING CATHETER

Cardiovascular · 90d