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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 K151638
Device Name Phenom 17 Catheter, Phenom 21 Catheter, Phenom 27 Catheter, Phenom Plus Catheter
Applicant
Cathera, Inc.
627 National Ave.
Mountain View,  CA  94043
Applicant Contact Victor Ham
Correspondent
Cathera, Inc.
627 National Ave.
Mountain View,  CA  94043
Correspondent Contact Victor Ham
Regulation Number870.1250
Classification Product Code
DQY  
Subsequent Product Code
KRA  
Date Received06/17/2015
Decision Date 11/13/2015
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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