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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 K862190
Device Name WALRUS: DOUBLE BALLOON SHUNTING CATHETER
Applicant
Medical Parameters, Inc.
20 Cabot Rd.
Woburn,  MA  01801
Applicant Contact WALTER MACEACHERN
Correspondent
Medical Parameters, Inc.
20 Cabot Rd.
Woburn,  MA  01801
Correspondent Contact WALTER MACEACHERN
Regulation Number870.4210
Classification Product Code
DWF  
Date Received06/09/1986
Decision Date 11/03/1986
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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