CBIS CATHETER PULL-BACK DEVICE

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 Cbis Catheter Pull-back Device.

Pre-market Notification Details

Device IDK921879
510k NumberK921879
Device Name:CBIS CATHETER PULL-BACK DEVICE
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 Received1992-04-20
Decision Date1992-07-16

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