BD Intima II Closed IV Catheter System, BD Intima II PLUS Closed IV Catheter System

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 Intima Ii Closed Iv Catheter System, Bd Intima Ii Plus Closed Iv Catheter System.

Pre-market Notification Details

Device IDK200891
510k NumberK200891
Device Name:BD Intima II Closed IV Catheter System, BD Intima II PLUS Closed IV Catheter System
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 Received2020-04-03
Decision Date2021-06-02

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