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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 K032041
Device Name DISTAL PERFUSION CATHETER (1.5 CM) AND (2.5CM)
Applicant
LeMaitre Vascular, Inc.
63 2nd Ave.
Bedford,  MA  01803
Applicant Contact CARLOS CHAPARRO
Correspondent
LeMaitre Vascular, Inc.
63 2nd Ave.
Bedford,  MA  01803
Correspondent Contact CARLOS CHAPARRO
Regulation Number870.4210
Classification Product Code
DWF  
Date Received07/01/2003
Decision Date 08/27/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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