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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic
510(k) Number K261648
Device Name Evident Vascular™ Guidance System
Applicant
Evident Vascular, Inc.
142 Charcot Ave.
San Jose,  CA  95131
Applicant Contact Danielo Piazza
Correspondent
Sparq Compliance
2624 Wagner Pl.
El Dorado Hills,  CA  95762
Correspondent Contact Angela Frederickson
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Codes
ITX   OBJ  
Date Received05/18/2026
Decision Date 10/28/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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