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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Injector And Syringe, Angiographic
510(k) Number K090621
Device Name FLOWCARDIA FLOWMATER INJECTOR, MODEL INJ 100
Applicant
Flowcardia, Inc.
745 N. Pastoria Ave.
Sunnyvale,  CA  94085
Applicant Contact Dustin Michaels
Correspondent
Flowcardia, Inc.
745 N. Pastoria Ave.
Sunnyvale,  CA  94085
Correspondent Contact Dustin Michaels
Regulation Number870.1650
Classification Product Code
DXT  
Date Received03/09/2009
Decision Date 06/19/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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