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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K211806
Device Name Venclose digiRF Generator with Maven Catheter, Venclose Maven System, Venclose digiRF Generator, Venclose Maven Catheter
Applicant
Venclose, Inc.
2570 N. 1st St., Floor 2, #221
San Jose,  CA  95131
Applicant Contact Mai-Ly Wilcox
Correspondent
Venclose, Inc.
2570 N. 1st St., Floor 2, #221
San Jose,  CA  95131
Correspondent Contact Mai-Ly Wilcox
Regulation Number878.4400
Classification Product Code
GEI  
Date Received06/11/2021
Decision Date 08/03/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
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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