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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 K251238
Device Name Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000); Vasoview Hemopro 3 Endoscopic Vessel Harvesting System with Vasoshield (VH-6001); Vasoview Hemopro 3 Power Supply (VH-6010)
Applicant
Maquet Cardiovascular, LLC
45 Barbour Pond Rd.
Wayne,  NJ  07470
Applicant Contact Brad Sheals
Correspondent
Maquet Cardiovascular, LLC
45 Barbour Pond Rd.
Wayne,  NJ  07470
Correspondent Contact Brad Sheals
Regulation Number878.4400
Classification Product Code
GEI  
Date Received04/22/2025
Decision Date 05/30/2025
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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