VAMP Venous/Arterial Blood Management Protection System

Catheter, Continuous Flush

Edwards Lifesciences, LLC

The following data is part of a premarket notification filed by Edwards Lifesciences, Llc with the FDA for Vamp Venous/arterial Blood Management Protection System.

Pre-market Notification Details

Device IDK173586
510k NumberK173586
Device Name:VAMP Venous/Arterial Blood Management Protection System
ClassificationCatheter, Continuous Flush
Applicant Edwards Lifesciences, LLC One Edwards Way Irvine,  CA  92618
ContactYe Seul Kim
CorrespondentYe Seul Kim
Edwards Lifesciences, LLC One Edwards Way Irvine,  CA  92618
Product CodeKRA  
CFR Regulation Number870.1210 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-11-20
Decision Date2018-04-05
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00690103001341 K173586 000
07460691950566 K173586 000
07460691950573 K173586 000
07460691950597 K173586 000
07460691950603 K173586 000
07460691950610 K173586 000
07460691951792 K173586 000
07460691951808 K173586 000
07460691957510 K173586 000
07460691959415 K173586 000
57460691959519 K173586 000

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