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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 Occluding, Temporary
510(k) Number K243795
Device Name pREBOA-PRO Catheter
Applicant
Prytime Medical Devices, Inc.
12 Upper Balcones Rd.
Boerne,  TX  78006
Applicant Contact Brian Young
Correspondent
Prytime Medical Devices, Inc.
12 Upper Balcones Rd.
Boerne,  TX  78006
Correspondent Contact Jeanette Losole
Regulation Number870.4450
Classification Product Code
MJN  
Date Received12/10/2024
Decision Date 09/05/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Clinical Trials NCT00459160
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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