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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 K220808
Device Name Tigertriever 13 Revascularization Device
Applicant
Rapid Medical , Ltd.
Carmel Bldg., Pob 337
Yokneam,  IL 2069205
Applicant Contact Orit Yaniv
Correspondent
Hogan Lovells US LLP
1735 Market St.,
23rd Floor
Philadelphia,  PA  19103
Correspondent Contact Janice Hogan
Regulation Number870.1250
Classification Product Code
NRY  
Date Received03/18/2022
Decision Date 07/25/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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