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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Thrombus Retriever
510(k) Number K230429
Device Name Tigertriever 21 Revascularization Device, Tigertriever 17 Revascularization Device, Tigertriever 13 Revascularization Device
Applicant
Rapid Medical , Ltd.
Carmel Bldg., Pob 337
Yokneam,  IL 2069205
Applicant Contact Orit Yaniv
Correspondent
Rapid Medical , Ltd.
Carmel Bldg., Pob 337
Yokneam,  IL 2069205
Correspondent Contact Orit Yaniv
Regulation Number870.1250
Classification Product Code
NRY  
Date Received02/17/2023
Decision Date 04/17/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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