K-number	K052454
Device name	THE EMBOSHIELD EMBOLIC PROTECTION SYSTEM
Applicant	Abbott Vascular Devices
Product code	NTE
Device class	Class II
Decision date	Sep 14, 2005
Decision	Substantially Equivalent
Regulation	870.1250

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Source

View the full FDA submission: accessdata.fda.gov

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THE EMBOSHIELD EMBOLIC PROTECTION SYSTEM

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