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Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Cardiovascular Imaging Systems, Inc. — Predicate Candidate Screening

19 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

91 daysmedian FDA review time
183 days90th percentile
19clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K970049BSC, SONICATH ULTRA IMAGING CATHETER 3.2F/20MHZ(37410/456221Cardiovascular Imaging Systems, Inc.1997-06-201650
K942231MICROVIEW II/MICRORAIL II CATHETERSCardiovascular Imaging Systems, Inc.1994-08-01870
K933517AUTOMATIC PULL BACK DEVICECardiovascular Imaging Systems, Inc.1993-10-15870
K930232CVIS INSIGHT IMAGING GUIDE CATHETERCardiovascular Imaging Systems, Inc.1993-07-211830
K924922CVIS INSIGHT IMAGING CATHETERCardiovascular Imaging Systems, Inc.1993-06-293300
K930311CVIS LONGVIEWCardiovascular Imaging Systems, Inc.1993-06-021320
K921879CBIS CATHETER PULL-BACK DEVICECardiovascular Imaging Systems, Inc.1992-07-16870
K921750CVIS INSIGHT III SYSTEMCardiovascular Imaging Systems, Inc.1992-07-13910
K921631CVIS INSIGHT IMAGING CATHETER FOR INTRALUMINALCardiovascular Imaging Systems, Inc.1992-07-02870
K921147CVIS INSIGHT IMAGING CATHETER FOR INTRALUMINAL USECardiovascular Imaging Systems, Inc.1992-06-16970
K921148CVIS INSIGHT CATHETERS FOR INTRACARDIAC USECardiovascular Imaging Systems, Inc.1992-06-16970
K911414CVIS INSIGHT IMAGING CATHETERSCardiovascular Imaging Systems, Inc.1991-09-111630
K904618CVIS INSIGHT IMAGING CATHETERCardiovascular Imaging Systems, Inc.1991-04-121830
K905625CVIS INSIGHT IMAGING CATHETERCardiovascular Imaging Systems, Inc.1991-02-21690
K901562CVIS INSIGHT IMAGING CATHETERCardiovascular Imaging Systems, Inc.1990-07-09970
K901691CVIS INSIGHT 15MHZ CATHETERS FOR PERIPHERAL USECardiovascular Imaging Systems, Inc.1990-07-06870
K897153CVIS INSIGHT IMAGING CATHETERCardiovascular Imaging Systems, Inc.1990-03-26900
K893837CVIS ULTRA-SCAN ONE IMAGING CATHETERCardiovascular Imaging Systems, Inc.1989-08-22900
K891386CVIS ULTRA-SCAN ONE IMAGING SYSTEMCardiovascular Imaging Systems, Inc.1989-05-16680

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda