Name: Predicase
Price: 199 USD

K-number	K083214
Device name	AMPLATZER TORQVUE 45DEGREEX45DEGREE DELIVERY SHEATH, MODELS 9-TV45X45-09F-100, 9-TV45X45-10F-100
Applicant	Aga Medical Corp.
Product code	DQY
Device class	Class II
Decision date	May 12, 2009
Decision	Substantially Equivalent
Regulation	870.1250

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Source

View the full FDA submission: accessdata.fda.gov

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AMPLATZER TORQVUE 45DEGREEX45DEGREE DELIVERY SHEATH, MODELS 9-TV45X45-09F-100, 9-TV45X45-10F-100

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