Name: Predicase
Price: 199 USD

K-number	K062429
Device name	MODIFICATION TO EMBOL-X INTRA-AORTIC FILTER: X-SMALL, SMALL, MEDIUM, LARGE, X-LARGE WITH HEPARIN COATED MESH
Applicant	Edwards Lifesciences Research Medical
Product code	DTM
Device class	Class II
Decision date	Sep 27, 2006
Decision	Substantially Equivalent
Regulation	870.4260

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Source

View the full FDA submission: accessdata.fda.gov

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MODIFICATION TO EMBOL-X INTRA-AORTIC FILTER: X-SMALL, SMALL, MEDIUM, LARGE, X-LARGE WITH HEPARIN COATED MESH

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