Nitroglycerin Sets With DUO-VENT Spike

Set, Administration, Intravascular

BAXTER HEALTHCARE CORPORATION

The following data is part of a premarket notification filed by Baxter Healthcare Corporation with the FDA for Nitroglycerin Sets With Duo-vent Spike.

Pre-market Notification Details

Device IDK150860
510k NumberK150860
Device Name:Nitroglycerin Sets With DUO-VENT Spike
ClassificationSet, Administration, Intravascular
Applicant BAXTER HEALTHCARE CORPORATION 32650 N. WILSON ROAD Round Lake,  IL  60073
ContactDhiraj Bizzul
CorrespondentMark Job
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeFPA  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2015-04-01
Decision Date2015-04-16
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
50085412051845 K150860 000
50085412046360 K150860 000
50085412019999 K150860 000
50085412002755 K150860 000

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