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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 K193322
Device Name NovaCross CTO Microcatheter
Applicant
Nitiloop , Ltd.
1st Tidar St.
Pardes Hanna,  IL 3701000
Applicant Contact Amir Pansky
Correspondent
Boston Biomedical Associates, LLC
One Crowley Dr., Suite 216
Marlborough,  MA  01752
Correspondent Contact Wanda Carpinella
Regulation Number870.1250
Classification Product Code
DQY  
Date Received12/02/2019
Decision Date 04/02/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Clinical Trials NCT02477579
NCT03717675
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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