CVIS LONGVIEW

Catheter, Intravascular, Diagnostic

CARDIOVASCULAR IMAGING SYSTEMS, INC.

The following data is part of a premarket notification filed by Cardiovascular Imaging Systems, Inc. with the FDA for Cvis Longview.

Pre-market Notification Details

Device IDK930311
510k NumberK930311
Device Name:CVIS LONGVIEW
ClassificationCatheter, Intravascular, Diagnostic
Applicant CARDIOVASCULAR IMAGING SYSTEMS, INC. 595 NORTH PASTORIA AVE. Sunnyvale,  CA  94085
ContactStan E Tillman
CorrespondentStan E Tillman
CARDIOVASCULAR IMAGING SYSTEMS, INC. 595 NORTH PASTORIA AVE. Sunnyvale,  CA  94085
Product CodeDQO  
CFR Regulation Number870.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-01-21
Decision Date1993-06-02

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.