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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 K143608
Device Name NovaCross Microcatheter
Applicant
Nitiloop , Ltd.
8 Hamada St.
P.O.Box 12892
Herzliya,  IL 46733
Applicant Contact Michael A Daniel
Correspondent
Daniel & Daniel Consulting
340 Jones Ln.
Gardnerville,  NV  89460
Correspondent Contact Michael A Daniel
Regulation Number870.1250
Classification Product Code
DQY  
Date Received12/19/2014
Decision Date 05/04/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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