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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Flow Directed
510(k) Number K892530
Device Name CATHETERS FOR BALLOON OCCLUSION FEMORAL ANGIOGRAPH
Applicant
Arrow Intl., Inc.
P.O. Box 6306
Hill And George Ave.s
Reading,  PA  19610
Applicant Contact THOMAS NICKEL
Correspondent
Arrow Intl., Inc.
P.O. Box 6306
Hill And George Ave.s
Reading,  PA  19610
Correspondent Contact THOMAS NICKEL
Regulation Number870.1240
Classification Product Code
DYG  
Date Received04/11/1989
Decision Date 09/26/1989
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
Recalls CDRH Recalls
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