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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 K232437
Device Name Paragon 8F Balloon Guide Catheter
Applicant
Wallaby Medical
22901 Mill Creek Dr.
Laguna Hills,  CA  92653
Applicant Contact Joseph Tang
Correspondent
Wallaby Medical
22901 Mill Creek Dr.
Laguna Hills,  CA  92653
Correspondent Contact Joseph Tang
Regulation Number870.1250
Classification Product Code
DQY  
Subsequent Product Code
QJP  
Date Received08/14/2023
Decision Date 10/13/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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