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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 K881352
Device Name RIGHT ATRIAL CATHETER INSERTION TRAY
Applicant
Quinton, Inc.
2121 Terry Ave.
Seattle,  WA  98121
Applicant Contact RON R DUCK
Correspondent
Quinton, Inc.
2121 Terry Ave.
Seattle,  WA  98121
Correspondent Contact RON R DUCK
Regulation Number870.4210
Classification Product Code
DWF  
Date Received03/30/1988
Decision Date 06/09/1988
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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