Name: Predicase
Price: 199 USD

K-number	K113775
Device name	FLASH-C PTCA BALLOON DILATATION CATHETER- 4.0MM X 14MM X 135CM -4.0MM X 19MM X 135CM- 4.5MM X 14MM X 135CM-4.5MM X 19MM
Applicant	Ostial Corporation
Product code	LOX
Device class	Class II
Decision date	Jun 29, 2012
Decision	Substantially Equivalent
Regulation	870.5100

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Source

View the full FDA submission: accessdata.fda.gov

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FLASH-C PTCA BALLOON DILATATION CATHETER- 4.0MM X 14MM X 135CM -4.0MM X 19MM X 135CM- 4.5MM X 14MM X 135CM-4.5MM X 19MM

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