BD Vacutainer UltraTouch Push Button Blood Collection Set

Tubes, Vials, Systems, Serum Separators, Blood Collection

BECTON, DICKINSON AND COMPANY

The following data is part of a premarket notification filed by Becton, Dickinson And Company with the FDA for Bd Vacutainer Ultratouch Push Button Blood Collection Set.

Pre-market Notification Details

Device IDK153309
510k NumberK153309
Device Name:BD Vacutainer UltraTouch Push Button Blood Collection Set
ClassificationTubes, Vials, Systems, Serum Separators, Blood Collection
Applicant BECTON, DICKINSON AND COMPANY 1 BECTON DRIVE Franklin Lakes,  NJ  07417
ContactPasquale Amato
CorrespondentPasquale Amato
BECTON, DICKINSON AND COMPANY 1 BECTON DRIVE Franklin Lakes,  NJ  07417
Product CodeJKA  
CFR Regulation Number862.1675 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-11-17
Decision Date2016-02-12
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
50382903673938 K153309 000
50382903673921 K153309 000
50382903673914 K153309 000
50382903673655 K153309 000
50382903673648 K153309 000
50382903673631 K153309 000

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