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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 K130649
Device Name SILK ROAD ACCESS CATHETER
Applicant
Silk Road Medical, Inc.
735 N. Pastoria Ave.
Sunnyvale,  CA  94085
Applicant Contact RICHARD M RUEDY
Correspondent
Silk Road Medical, Inc.
735 N. Pastoria Ave.
Sunnyvale,  CA  94085
Correspondent Contact RICHARD M RUEDY
Regulation Number870.1250
Classification Product Code
DQY  
Subsequent Product Code
KRA  
Date Received03/11/2013
Decision Date 11/01/2013
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
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