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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K112335
Device Name BANTAM CATHETER (280MM BALLOON LENGTHS)
Applicant
CLEAR STREAM TECHNOLOGIES, LTD.
MOYNE UPPER, ENNISCORTHY
COUNTY WEXFORD,  IE
Applicant Contact FIONA NI MHULLAIN
Correspondent
DEKRA CERTIFICATION B.V.
UTRECHTSEWEG 310
ARNHEM,  NL NL-6812 AR
Correspondent Contact J.A. VAN VUGT
Regulation Number870.1250
Classification Product Code
DQY  
Subsequent Product Code
LIT  
Date Received08/12/2011
Decision Date 10/12/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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