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 Plus Closed Iv Catheter System.

Pre-market Notification Details

Device IDK172204
510k NumberK172204
Device Name: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
ContactHenry Boland
CorrespondentMark Job
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeFOZ  
CFR Regulation Number880.5200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2017-07-21
Decision Date2017-08-17
Summary:summary

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