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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
510(k) Number K200289
Device Name Michler-Kapp Cardiovascular Vent Catheter
Applicant
Kapp Surgical Instrument, Inc.
4919 Warrensville Center Rd.
Warrensville,  OH  44128
Applicant Contact Nicole Merrifield
Correspondent
Cro Group, Inc.
342 Main St.
Leola,  PA  17540
Correspondent Contact William McLain
Regulation Number870.4210
Classification Product Code
DWF  
Date Received02/05/2020
Decision Date 01/28/2021
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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