AMPLATZER VASCULAR PLUG 4

Device, Vascular, For Promoting Embolization

AGA MEDICAL CORP.

The following data is part of a premarket notification filed by Aga Medical Corp. with the FDA for Amplatzer Vascular Plug 4.

Pre-market Notification Details

Device IDK113658
510k NumberK113658
Device Name:AMPLATZER VASCULAR PLUG 4
ClassificationDevice, Vascular, For Promoting Embolization
Applicant AGA MEDICAL CORP. 5050 NATHAN LANE NORTH Plymouth,  MN  55442
ContactSherry Kollmann
CorrespondentSherry Kollmann
AGA MEDICAL CORP. 5050 NATHAN LANE NORTH Plymouth,  MN  55442
Product CodeKRD  
CFR Regulation Number870.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-12-12
Decision Date2012-06-12
Summary:summary

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