Name: Predicase
Price: 199 USD

K-number	K122178
Device name	FLASH-C PTCA BALLOON DILATATION CATHETER - 4MM X 14MM X 135CM, FLASH-C PTCA BALLOON DILATATION CATHETER - 4MM X 19MM X 1
Applicant	Ostial Corporation
Product code	LOX
Device class	Class II
Decision date	Oct 11, 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 - 4MM X 14MM X 135CM, FLASH-C PTCA BALLOON DILATATION CATHETER - 4MM X 19MM X 1

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