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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 K051580
Device Name VP SHEATH
Applicant
Flowcardia, Inc.
745 N. Pastoria Ave.
Sunnyvale,  CA  94085
Applicant Contact RICHARD SPANO
Correspondent
Flowcardia, Inc.
745 N. Pastoria Ave.
Sunnyvale,  CA  94085
Correspondent Contact RICHARD SPANO
Regulation Number870.1250
Classification Product Code
DQY  
Date Received06/15/2005
Decision Date 10/31/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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