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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
510(k) Number K243105
Device Name Ruby Intravascular Catheter
Applicant
Venocare, Inc.
8750 NW 36 St., Suite 630
Doral,  FL  33178
Applicant Contact Raul Leyte-Vidal
Correspondent
Daniel & Daniel, LLC
P.O. Box 129
Minden,  NV  89423
Correspondent Contact Mark Smutka
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received09/30/2024
Decision Date 05/16/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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