K-number	K080994
Device name	AMPLATZER TORQVUE EXCHANGE SYSTEM
Applicant	Aga Medical Corp.
Product code	DQY
Device class	Class II
Decision date	May 16, 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 EXCHANGE SYSTEM

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