SMARTSITE VENTED VIAL ACCESS DEVICE, MODEL TBD

Set, I.v. Fluid Transfer

CARDINAL HEALTH, ALARIS PRODUCTS

The following data is part of a premarket notification filed by Cardinal Health, Alaris Products with the FDA for Smartsite Vented Vial Access Device, Model Tbd.

Pre-market Notification Details

Device IDK052790
510k NumberK052790
Device Name:SMARTSITE VENTED VIAL ACCESS DEVICE, MODEL TBD
ClassificationSet, I.v. Fluid Transfer
Applicant CARDINAL HEALTH, ALARIS PRODUCTS 10221 WATERIDGE CIRCLE San Diego,  CA  92121 -2772
ContactStacy L Lewis
CorrespondentStacy L Lewis
CARDINAL HEALTH, ALARIS PRODUCTS 10221 WATERIDGE CIRCLE San Diego,  CA  92121 -2772
Product CodeLHI  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-10-03
Decision Date2005-12-23
Summary:summary

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