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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 K082385
Device Name CHAPERON GUIDING CATHETER
Original Applicant
MICROVENTION, INC.
75 columbia
aliso viejo,  CA  92656 1408
Original Contact florin truuvert
Regulation Number870.1250
Classification Product Code
DQY  
Date Received08/19/2008
Decision Date 12/11/2008
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party Yes
Expedited Review No
Combination Product No
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