DESERET(R) I.V. LOOP AND DESERET (R) J LOOP

Set, Administration, Intravascular

BECTON DICKINSON VASCULAR ACCESS, INC.

The following data is part of a premarket notification filed by Becton Dickinson Vascular Access, Inc. with the FDA for Deseret(r) I.v. Loop And Deseret (r) J Loop.

Pre-market Notification Details

Device IDK950303
510k NumberK950303
Device Name:DESERET(R) I.V. LOOP AND DESERET (R) J LOOP
ClassificationSet, Administration, Intravascular
Applicant BECTON DICKINSON VASCULAR ACCESS, INC. 9450 SOUTH STATE ST. Sandy,  UT  84070
ContactC. J Welle
CorrespondentC. J Welle
BECTON DICKINSON VASCULAR ACCESS, INC. 9450 SOUTH STATE ST. Sandy,  UT  84070
Product CodeFPA  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-01-25
Decision Date1995-03-14

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
50382903851213 K950303 000
50382903851206 K950303 000

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