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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, percutaneous
510(k) Number K073289
Device Name MICROSHEATH XL CATHETERS
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 Number870.1250
Classification Product Code
DQY  
Date Received11/21/2007
Decision Date 01/11/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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