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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 K203592
Device Name Tigertriever and Tigertriever 17 Revascularization Devce
Applicant
Rapid Medical Ltd.
Carmel Building, POB 337
Yokneam,  IL 2069205
Applicant Contact Orit Yaniv
Correspondent
Hogan Lovells US LLP
1735 Market Street, 23rd Floor
Philadelphia,  PA  19103
Correspondent Contact Janice Hogan
Regulation Number870.1250
Classification Product Code
NRY  
Date Received12/08/2020
Decision Date 03/23/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Traditional
Clinical Trials NCT03474549
Reviewed by Third Party No
Combination Product No
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