Name: Predicase
Price: 199 USD

K-number	K111738
Device name	CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) GUIDE WIRE (0.014 AND 0.018)
Applicant	Trireme Medical, Inc.
Product code	DQY
Device class	Class II
Decision date	Dec 14, 2011
Decision	Substantially Equivalent
Regulation	870.1250

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Source

View the full FDA submission: accessdata.fda.gov

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CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) GUIDE WIRE (0.014 AND 0.018)

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