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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wire, Guide, Catheter
510(k) Number K250203
Device Name SureAx-Guide™
Applicant
Sureax Medical, LLC
11107 Roselle St. Suite 237
San Diego,  CA  92121
Applicant Contact Ricardo Villanueva
Correspondent
Starlight Medical Consulting
203 Providence Falls Trl.
Hurdle Mills,  NC  27541
Correspondent Contact Natalie Eagleburger
Regulation Number870.1330
Classification Product Code
DQX  
Date Received01/24/2025
Decision Date 10/17/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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