Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Cardiovascular Imaging Systems, Inc.

FDA 510(k) & PMA Approved Devices — 19 products

Total Devices19
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K970049 BSC, SONICATH ULTRA IMAGING CATHETER 3.2F/20MHZ(37410/456221 & BSC, SONICATH ULTRA IMAGING CATHETER 2.9F/20MHZ/37411/ITX1997-06-20 View
510(k) K942231 MICROVIEW II/MICRORAIL II CATHETERSDQO1994-08-01 View
510(k) K933517 AUTOMATIC PULL BACK DEVICEDQX1993-10-15 View
510(k) K930232 CVIS INSIGHT IMAGING GUIDE CATHETERDQO1993-07-21 View
510(k) K924922 CVIS INSIGHT IMAGING CATHETERDQO1993-06-29 View
510(k) K930311 CVIS LONGVIEWDQO1993-06-02 View
510(k) K921879 CBIS CATHETER PULL-BACK DEVICEDQO1992-07-16 View
510(k) K921750 CVIS INSIGHT III SYSTEMITX1992-07-13 View
510(k) K921631 CVIS INSIGHT IMAGING CATHETER FOR INTRALUMINALITX1992-07-02 View
510(k) K921147 CVIS INSIGHT IMAGING CATHETER FOR INTRALUMINAL USEITX1992-06-16 View
510(k) K921148 CVIS INSIGHT CATHETERS FOR INTRACARDIAC USEITX1992-06-16 View
510(k) K911414 CVIS INSIGHT IMAGING CATHETERSITX1991-09-11 View
510(k) K904618 CVIS INSIGHT IMAGING CATHETERDQO1991-04-12 View
510(k) K905625 CVIS INSIGHT IMAGING CATHETERDQO1991-02-21 View
510(k) K901562 CVIS INSIGHT IMAGING CATHETERDXK1990-07-09 View
510(k) K901691 CVIS INSIGHT 15MHZ CATHETERS FOR PERIPHERAL USEDQO1990-07-06 View
510(k) K897153 CVIS INSIGHT IMAGING CATHETERLYK1990-03-26 View
510(k) K893837 CVIS ULTRA-SCAN ONE IMAGING CATHETERIYO1989-08-22 View
510(k) K891386 CVIS ULTRA-SCAN ONE IMAGING SYSTEMIYO1989-05-16 View
↑