CADD CHECKVALVE ADMINISTRATION SET, MODEL 21-7090

Set, Administration, Intravascular

SIMS DELTEC, INC.

The following data is part of a premarket notification filed by Sims Deltec, Inc. with the FDA for Cadd Checkvalve Administration Set, Model 21-7090.

Pre-market Notification Details

Device IDK000942
510k NumberK000942
Device Name:CADD CHECKVALVE ADMINISTRATION SET, MODEL 21-7090
ClassificationSet, Administration, Intravascular
Applicant SIMS DELTEC, INC. 1265 GREY FOX RD. St. Paul,  MN  55112
ContactLisa Stone
CorrespondentLisa Stone
SIMS DELTEC, INC. 1265 GREY FOX RD. St. Paul,  MN  55112
Product CodeFPA  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-03-23
Decision Date2000-04-27

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
30610586034507 K000942 000

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