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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular Occluding, Temporary
510(k) Number K183045
Device Name Eclipse 2L
Applicant
Balt USA, LLC
29 Parker
Irvine,  CA  92618
Applicant Contact Nancy Xu
Correspondent
Balt USA, LLC
29 Parker
Irvine,  CA  92618
Correspondent Contact Nancy Xu
Regulation Number870.4450
Classification Product Code
MJN  
Subsequent Product Code
DQY  
Date Received11/02/2018
Decision Date 04/30/2019
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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