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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 K073318
Device Name BIPORE BALLOON DILATION CATHETER
Applicant
Bipore, Inc.
31 Industrial Pkwy.
Northvale,  NJ  07647
Applicant Contact KEITH PALUCH
Correspondent
Bipore, Inc.
31 Industrial Pkwy.
Northvale,  NJ  07647
Correspondent Contact KEITH PALUCH
Regulation Number870.1250
Classification Product Code
LIT  
Date Received11/26/2007
Decision Date 01/16/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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