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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 K254006
Device Name Drivewire 35 Guidewire
Applicant
Rapid Medical Ltd.
Carmel Bldg., Pob 337
Yokneam,  IL 2069205
Applicant Contact Ina Gutman
Correspondent
Rapid Medical Ltd.
Carmel Bldg., Pob 337
Yokneam,  IL 2069205
Correspondent Contact Ina Gutman
Regulation Number870.1330
Classification Product Code
MOF  
Subsequent Product Code
DQX  
Date Received12/15/2025
Decision Date 07/17/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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