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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Guide, Wire, Catheter, Neurovasculature
510(k) Number K200374
Device Name Columbus Guidewire
Applicant
Rapid-Medical , Ltd.
Carmel Bldg.
Pob 337
Yokneam,  IL 2069205
Applicant Contact Orit Yaniv
Correspondent
Hogan Lovells US LLP
1835 Market St., 29th Floor
Philedelphia,  PA  19103
Correspondent Contact Janice Hogan
Regulation Number870.1330
Classification Product Code
MOF  
Subsequent Product Code
DQX  
Date Received02/14/2020
Decision Date 12/14/2020
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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