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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Angioplasty, Peripheral, Transluminal
510(k) Number K942400
Device Name BARD PERIPHERAL BALLOON DILATATION CATHETER
Applicant
C.R. Bard, Inc.
10115 Hwy. 142
Covington,  GA  30209
Applicant Contact STEVEN F MERCEREAU
Correspondent
C.R. Bard, Inc.
10115 Hwy. 142
Covington,  GA  30209
Correspondent Contact STEVEN F MERCEREAU
Regulation Number870.1250
Classification Product Code
LIT  
Date Received05/19/1994
Decision Date 11/07/1994
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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