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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 K093139
Device Name BANTAM,48XXXXXX, 50XXXXXX
Applicant
ClearStream Technologies , Ltd.
Moyne Upper
Enniscorthy
Wexford,  IE
Applicant Contact FIONA NI MHULLAIN
Correspondent
ClearStream Technologies , Ltd.
Moyne Upper
Enniscorthy
Wexford,  IE
Correspondent Contact FIONA NI MHULLAIN
Regulation Number870.1250
Classification Product Code
LIT  
Date Received10/05/2009
Decision Date 12/30/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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