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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: Direct Flow Medical ® Transcatheter Aortic Valve System
Product Code: DYE
Device Class: 3
Regulation Number: 870.3925
Medical Specialty: Cardiovascular
Registered Establishment Name: Direct Flow Medical, Inc. - Lake Forest
Registered Establishment Number: 3008004214
Owner/Operator: Direct Flow Medical, Inc.
Owner/Operator Number: 10029284
Establishment Operations: Manufacturer