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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K852491
Device Name AMERICAN PHARMASEAL TRIPLE LUMEN CATHETER
Applicant
American Pharmaseal Div. Ahsc
1015 Grandview
P.O. Box 1300
Glendale,  CA  91209
Applicant Contact LAWRENCE W GETLIN
Correspondent
American Pharmaseal Div. Ahsc
1015 Grandview
P.O. Box 1300
Glendale,  CA  91209
Correspondent Contact LAWRENCE W GETLIN
Regulation Number870.1250
Classification Product Code
DQY  
Date Received06/12/1985
Decision Date 09/25/1985
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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