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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Clamp, Vascular
510(k) Number K914149
Device Name FEMORAL ARTERY PRESSURE PAD/DISK
Applicant
Disco, Inc.
6611 SW Burlingame Ave.
Portland,  OR  97201
Applicant Contact BYRON ZAHLER
Correspondent
Disco, Inc.
6611 SW Burlingame Ave.
Portland,  OR  97201
Correspondent Contact BYRON ZAHLER
Regulation Number870.4450
Classification Product Code
DXC  
Date Received09/16/1991
Decision Date 12/13/1991
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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