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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 K854137
Device Name ARROW BRACHIAL CENTRAL VENOUS CATH-KIT W/16GA & EC
Applicant
Arrow Intl., Inc.
P.O. Box 6306
Hill And George Ave.S
Reading,  PA  19610
Applicant Contact RONALD P CITRON
Correspondent
Arrow Intl., Inc.
P.O. Box 6306
Hill And George Ave.S
Reading,  PA  19610
Correspondent Contact RONALD P CITRON
Regulation Number870.1250
Classification Product Code
DQY  
Date Received10/10/1985
Decision Date 12/03/1985
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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