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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
FOIA Releasable 510(k) K082385
Device Name CHAPERON GUIDING CATHETER
Applicant
MicroVention, Inc.
75 Columbia
Aliso Viejo,  CA  92656 -1408
Applicant Contact FLORIN TRUUVERT
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number870.1250
Classification Product Code
DQY  
Date Received08/19/2008
Decision Date 12/11/2008
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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