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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 K844140
Device Name STOCKERT-SHILEY ATRIAL LEFT VENTRICULAR VENT CATH
Applicant
Shiley, Inc.
17600 Gillette Ave.
Applicant Contact ROBERT CURTIS
Correspondent
Shiley, Inc.
17600 Gillette Ave.
Correspondent Contact ROBERT CURTIS
Regulation Number870.4210
Classification Product Code
DWF  
Date Received10/23/1984
Decision Date 12/27/1984
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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