Name: Predicase
Price: 199 USD

K-number	K162228
Device name	TorqVue Low Profile Delivery Catheter
Applicant	Aga Medical Corporation (Wholly Owned by St.Jude Medical Cor
Product code	DQY
Device class	Class II
Decision date	Sep 9, 2016
Decision	Substantially Equivalent
Regulation	870.1250

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Source

View the full FDA submission: accessdata.fda.gov

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TorqVue Low Profile Delivery Catheter

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