Name: Predicase
Price: 199 USD

K-number	K163000
Device name	AMPLATZER TorqVue 45x45 Delivery Sheath
Applicant	Aga Medical COrporation (Wholly Owned by St. Jude Medical CO
Product code	DQY
Device class	Class II
Decision date	Dec 23, 2016
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 45x45 Delivery Sheath

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