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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Port & Catheter, Implanted, Subcutaneous, Intravascular
510(k) Number K260916
Device Name FLEXI-PORT™ Power Injectable Implantable Port
Applicant
Portal Access, Inc.
4201 Collins Ave.
Apt. 601
Miami Beach,  FL  33140
Applicant Contact Hila Ravid
Correspondent
Portal Access, Inc.
4201 Collins Ave.
Apt. 601
Miami Beach,  FL  33140
Correspondent Contact Hila Ravid
Regulation Number880.5965
Classification Product Code
LJT  
Date Received03/19/2026
Decision Date 06/17/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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