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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 K203487
Device Name Drakon and Sequre Microcatheters
Applicant
Accurate Medical Therapeutics, Ltd.
19 Eli Hurvitz St.
Rehovot,  IL 7608802
Applicant Contact Osnat Harbater
Correspondent
Accurate Medical Therapeutics, Ltd.
19 Eli Hurvitz St.
Rehovot,  IL 7608802
Correspondent Contact Osnat Harbater
Regulation Number870.1200
Classification Product Code
DQO  
Date Received11/27/2020
Decision Date 12/11/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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