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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 K012617
Device Name JOSTRA ARTERIAL PERFUSION CANNULAE, MODEL A...
Applicant
Jostra AG
P.O. Box 218
Oxford,  PA  19363
Applicant Contact KATHLEEN JOHNSON
Correspondent
Jostra AG
P.O. Box 218
Oxford,  PA  19363
Correspondent Contact KATHLEEN JOHNSON
Regulation Number870.4210
Classification Product Code
DWF  
Date Received08/13/2001
Decision Date 11/06/2001
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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