BD Insyte Autoguard Shielded IV Catheter, BD Insyte Autoguard BC Shielded IV Catheter, BD Insyte Autoguard BC Pro Shielded IV Catheter

Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

Becton, Dickinson And Company

The following data is part of a premarket notification filed by Becton, Dickinson And Company with the FDA for Bd Insyte Autoguard Shielded Iv Catheter, Bd Insyte Autoguard Bc Shielded Iv Catheter, Bd Insyte Autoguard Bc Pro Shielded Iv Catheter.

Pre-market Notification Details

Device IDK201075
510k NumberK201075
Device Name:BD Insyte Autoguard Shielded IV Catheter, BD Insyte Autoguard BC Shielded IV Catheter, BD Insyte Autoguard BC Pro Shielded IV Catheter
ClassificationCatheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Applicant Becton, Dickinson And Company 9450 South State Street Sandy,  UT  84070
ContactKimberly Geisler
CorrespondentKimberly Geisler
Becton, Dickinson And Company 9450 South State Street Sandy,  UT  84070
Product CodeFOZ  
CFR Regulation Number880.5200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-22
Decision Date2020-12-18

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