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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 K132652
Device Name VIA MICROCATHETER, VIA PLUS MICROCATHETER
Applicant
Sequent Medical, Inc.
11a Columbia
Aliso Viejo,  CA  92656
Applicant Contact MELANIE PARRAVI
Correspondent
Sequent Medical, Inc.
11a Columbia
Aliso Viejo,  CA  92656
Correspondent Contact MELANIE PARRAVI
Regulation Number870.1250
Classification Product Code
DQY  
Subsequent Product Code
KRA  
Date Received08/26/2013
Decision Date 12/20/2013
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
Recalls CDRH Recalls
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