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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K250972
Device Name Primum Hydrophilic Guiding Catheter
Applicant
Pendracare
Van Der Waalspark 20-22
Leek,  NL 9351VC
Applicant Contact Erendira Rodriguez
Correspondent
Pendracare
Van Der Waalspark 20-22
Leek,  NL 9351VC
Correspondent Contact Erendira Rodriguez
Regulation Number870.1250
Classification Product Code
DQY  
Date Received03/31/2025
Decision Date 06/29/2025
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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