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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 K890024
Device Name SARNS VENT CATHETER
Applicant
3M Company
6200 Jackson Rd.
P.O. Box 1247
Ann Arbor,  MI  48106
Applicant Contact JAMES BALUN
Correspondent
3M Company
6200 Jackson Rd.
P.O. Box 1247
Ann Arbor,  MI  48106
Correspondent Contact JAMES BALUN
Regulation Number870.4210
Classification Product Code
DWF  
Date Received01/04/1989
Decision Date 03/02/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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