Name: Predicase
Price: 199 USD

K-number	K093476
Device name	AMPLATZER TORQ VUE 2 DELIVERY SHEATH MODEL 9-TV2-05F120, MODEL 9-TV2-06F120, MODELTV-2-07F120
Applicant	Aga Medical Corp.
Product code	DQY
Device class	Class II
Decision date	Feb 5, 2010
Decision	Substantially Equivalent
Regulation	870.1250

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Source

View the full FDA submission: accessdata.fda.gov

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AMPLATZER TORQ VUE 2 DELIVERY SHEATH MODEL 9-TV2-05F120, MODEL 9-TV2-06F120, MODELTV-2-07F120

Everything you need for a 510(k) submission. Nothing you don't.