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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 K934411
Device Name MEADOX SURGIMED OLBERT CATHETER SYSTEM NOPROFILE
Applicant
Meadox Medicals, Div. Boston Scientific Corp.
112 Bauer Dr.
Oakland,  NJ  07045
Applicant Contact NANCY C KOFFMAN
Correspondent
Meadox Medicals, Div. Boston Scientific Corp.
112 Bauer Dr.
Oakland,  NJ  07045
Correspondent Contact NANCY C KOFFMAN
Regulation Number870.1250
Classification Product Code
LIT  
Date Received09/10/1993
Decision Date 01/07/1994
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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