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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 K191947
Device Name VASOVIEW HEMOPRO Extension Cable, VASOVIEW HEMOPRO 2 Extension Cable, Bipolar Extension Cable, Fixed Distance, Active Return Cord
Applicant
Maquet Cardiovascular, LLC
45 Barbour Pond Dr.
Wayne,  NJ  07470
Applicant Contact Mark Dinger
Correspondent
Maquet Cardiovascular, LLC
45 Barbour Pond Dr.
Wayne,  NJ  07470
Correspondent Contact Mark Dinger
Regulation Number878.4400
Classification Product Code
GEI  
Date Received07/22/2019
Decision Date 09/17/2019
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
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