Name: Predicase
Price: 199 USD

K-number	K102420
Device name	EMBOL-X ACCESS DEVICE/ AORTIC CANNULA, EMBOL-X SLIM ACCESSDEVICE/ AORTIC CANNULA, EMBOL-X GLIDE ACCESS DEVICE/ AORTIC CA
Applicant	Edwards Lifesciences, LLC
Product code	DWF
Device class	Class II
Decision date	Oct 26, 2010
Decision	Substantially Equivalent
Regulation	870.4210

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Source

View the full FDA submission: accessdata.fda.gov

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EMBOL-X ACCESS DEVICE/ AORTIC CANNULA, EMBOL-X SLIM ACCESSDEVICE/ AORTIC CANNULA, EMBOL-X GLIDE ACCESS DEVICE/ AORTIC CA

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