510(k) K252373 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
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 Techno
| Applicant | Spectrum Vascular, White Plains NY, US |
| Decision | Substantially Equivalent, Dec 16, 2025 |
| Received | Jul 30, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252373
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.