Cardiovascular Imaging Systems, Inc.

FDA Regulatory Profile

Cardiovascular Imaging Systems, Inc. appears in FDA public data with 0 recalls, 19 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on Jun 20, 1997.

Summary

Total Recalls
0
510(k) Clearances
19
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K970049BSC, SONICATH ULTRA IMAGING CATHETER 3.2F/20MHZ(37410/456221 & BSC, SONICATH ULTRA IMAGING CATHETER Jun 20, 1997
K942231MICROVIEW II/MICRORAIL II CATHETERSAug 1, 1994
K933517AUTOMATIC PULL BACK DEVICEOct 15, 1993
K930232CVIS INSIGHT IMAGING GUIDE CATHETERJul 21, 1993
K924922CVIS INSIGHT IMAGING CATHETERJun 29, 1993
K930311CVIS LONGVIEWJun 2, 1993
K921879CBIS CATHETER PULL-BACK DEVICEJul 16, 1992
K921750CVIS INSIGHT III SYSTEMJul 13, 1992
K921631CVIS INSIGHT IMAGING CATHETER FOR INTRALUMINALJul 2, 1992
K921148CVIS INSIGHT CATHETERS FOR INTRACARDIAC USEJun 16, 1992
K921147CVIS INSIGHT IMAGING CATHETER FOR INTRALUMINAL USEJun 16, 1992
K911414CVIS INSIGHT IMAGING CATHETERSSep 11, 1991
K904618CVIS INSIGHT IMAGING CATHETERApr 12, 1991
K905625CVIS INSIGHT IMAGING CATHETERFeb 21, 1991
K901562CVIS INSIGHT IMAGING CATHETERJul 9, 1990
K901691CVIS INSIGHT 15MHZ CATHETERS FOR PERIPHERAL USEJul 6, 1990
K897153CVIS INSIGHT IMAGING CATHETERMar 26, 1990
K893837CVIS ULTRA-SCAN ONE IMAGING CATHETERAug 22, 1989
K891386CVIS ULTRA-SCAN ONE IMAGING SYSTEMMay 16, 1989