BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology +6 more— 510(k) K252373

Clearance details

Device name as filed

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

Product code

Code LJS

Device class

Class 2

Regulation

21 CFR 880.5970

Advisory panel

General Hospital

Date received

2025-07-30

Decision date

2025-12-16

Decision

Substantially Equivalent

Clearance type

Traditional

Location

White Plains, NY, US

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Death

31

Injury

2,791

Malfunction

18,374

Other

5

Total

21,201

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →