Name: Predicase
Price: 199 USD

K-number	K052791
Device name	MODIFICATION TO: AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER
Applicant	Invatec Innovative Technologies, S.R.L.
Product code	DQY
Device class	Class II
Decision date	Nov 4, 2005
Decision	Substantially Equivalent
Regulation	870.1250

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Source

View the full FDA submission: accessdata.fda.gov

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MODIFICATION TO: AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER

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