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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Suture, Nonabsorbable, Synthetic, Polyethylene
510(k) Number K153096
Device Name LARIAT RS Suture Delivery Device
Applicant
Sentreheart, Inc.
300 Saginaw Dr.
Redwood City,  CA  94063
Applicant Contact KIT CARIQUITAN
Correspondent
Sentreheart, Inc.
300 Saginaw Dr.
Redwood City,  CA  94063
Correspondent Contact KIT CARIQUITAN
Regulation Number878.5000
Classification Product Code
GAT  
Subsequent Product Code
HCF  
Date Received10/26/2015
Decision Date 11/25/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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