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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, Diagnostic
510(k) Number K173430
Device Name SeQure® NF and SeQure® Microcatheters
Applicant
Accurate Medical Therapeutics, Ltd.
21 Habarzel St.
Tel-Aviv,  IL 6971029
Applicant Contact Eran Miller
Correspondent
Orly Maor
25a Sirkin St.
Kfar Saba,  IL 4442156
Correspondent Contact Orly Maor
Regulation Number870.1200
Classification Product Code
DQO  
Date Received11/02/2017
Decision Date 01/26/2018
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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