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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 K972261
Device Name RIVETTI-LEVINSON INSTRALUMINAL SHUNT
Applicant
Integra Neurocare, LLC
8401 102nd St.
Suite 200-P.O. Box 390
Pleasant Prairie,  WI  53150
Applicant Contact LORI L HAYS
Correspondent
Integra Neurocare, LLC
8401 102nd St.
Suite 200-P.O. Box 390
Pleasant Prairie,  WI  53150
Correspondent Contact LORI L HAYS
Regulation Number870.4210
Classification Product Code
DWF  
Date Received06/17/1997
Decision Date 09/15/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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