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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 K934127
Device Name SARNS LOW JETTING AORTIC ARCH CANNULA
Applicant
3M HEALTH CARE, SARNS
6200 JACKSON RD.
ANN ARBOR,  MI  48103
Applicant Contact JAMES BALUN
Correspondent
3M HEALTH CARE, SARNS
6200 JACKSON RD.
ANN ARBOR,  MI  48103
Correspondent Contact JAMES BALUN
Regulation Number870.4210
Classification Product Code
DWF  
Date Received08/25/1993
Decision Date 02/22/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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