
Spectrum Vascular
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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 is an FDA 510(k)-cleared medical device (K252373) manufactured by Spectrum Vascular. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 15, 2025. Regulation: 8.

Ansell
SKU MSC846624

Princeton BioMeditech Corp.
SKU K014192

McKesson
SKU VM-1270030

Hollister
SKU VM-1270031