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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dilator, Vessel, For Percutaneous Catheterization
510(k) Number K162181
Device Name Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set
Applicant
CARDIACASSIST INC.
240 ALPHA DRIVE
PITTSBURGH,  PA  15238
Applicant Contact GREG JOHNSON
Correspondent
CARDIACASSIST INC.
240 ALPHA DRIVE
PITTSBURGH,  PA  15238
Correspondent Contact GREG JOHNSON
Regulation Number870.1310
Classification Product Code
DRE  
Date Received08/04/2016
Decision Date 01/06/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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