AMPLATZER TORQVUE DELIVERY SYSTEM

Catheter, Percutaneous

AGA MEDICAL CORP.

The following data is part of a premarket notification filed by Aga Medical Corp. with the FDA for Amplatzer Torqvue Delivery System.

Pre-market Notification Details

Device IDK072313
510k NumberK072313
Device Name:AMPLATZER TORQVUE DELIVERY SYSTEM
ClassificationCatheter, Percutaneous
Applicant AGA MEDICAL CORP. 5050 NATHAN LANE NORTH Plymouth,  MN  55442
ContactPatricia A Laforte
CorrespondentPatricia A Laforte
AGA MEDICAL CORP. 5050 NATHAN LANE NORTH Plymouth,  MN  55442
Product CodeDQY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-08-17
Decision Date2007-11-02
Summary:summary

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