Name: Predicase
Price: 199 USD

K-number	K112398
Device name	TRIV(TM) VALVED TEARAWAY INTRODUCER, TIRV(TM) VALVED TEARAWAY INTRODUCER WITH SIDE PORT
Applicant	Galt Medical
Product code	DYB
Device class	Class II
Decision date	Apr 12, 2012
Decision	Substantially Equivalent
Regulation	870.1340

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Source

View the full FDA submission: accessdata.fda.gov

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TRIV(TM) VALVED TEARAWAY INTRODUCER, TIRV(TM) VALVED TEARAWAY INTRODUCER WITH SIDE PORT

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