K-number	K080757
Device name	AMPLATZER TORQVUE LOW PROFILE DELIVERY SYSTEM
Applicant	Aga Medical Corp.
Product code	DQY
Device class	Class II
Decision date	Apr 18, 2008
Decision	Substantially Equivalent
Regulation	870.1250

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View the full FDA submission: accessdata.fda.gov

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AMPLATZER TORQVUE LOW PROFILE DELIVERY SYSTEM

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