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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Guide, Wire, Catheter, Neurovasculature
510(k) Number K182337
Device Name HYBRID Guidewire
Applicant
Balt USA, LLC
29 Parker
Irvine,  CA  92618
Applicant Contact Nancy Xu
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number870.1330
Classification Product Code
MOF  
Subsequent Product Code
DQX  
Date Received08/28/2018
Decision Date 10/04/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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