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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, Long-Term Greater Than 30 Days
510(k) Number K252373
Device Name BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology; BioFlo Midline Catheter; Xcela Power Injectable PICC; Xcela PICC with PASV Valve Technology; Xcela Hybrid PICC with PASV Valve Technology
Applicant
Spectrum Vascular
50 Main St.
Suite 1000
White Plains,  NY  10606
Applicant Contact Sharon Klugewicz
Correspondent
Spectrum Vascular
50 Main St.
Suite 1000
White Plains,  NY  10606
Correspondent Contact Sharon Klugewicz
Regulation Number880.5970
Classification Product Code
LJS  
Subsequent Product Code
PND  
Date Received07/30/2025
Decision Date 12/16/2025
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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