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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 K843444
Device Name ARGYLE SILICONE LEFT VENTRICULAR AND
Applicant
Sherwood Medical Co.
1831 Olive St.
St. Louis,  MS  63103
Applicant Contact FRANK J FUCHILE
Correspondent
Sherwood Medical Co.
1831 Olive St.
St. Louis,  MS  63103
Correspondent Contact FRANK J FUCHILE
Regulation Number870.4210
Classification Product Code
DWF  
Date Received09/05/1984
Decision Date 10/18/1984
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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