Home / 510(k) Clearances / K252373

510(k) K252373

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 by Spectrum Vascular — Product Code LJS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 2025
Date Received
July 30, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Device Class
Class II
Regulation Number
880.5970
Review Panel
HO
Submission Type

Other clearances by Spectrum Vascular

  • K250724 — Intraosseous Infusion Needles (July 30, 2025)
  • K241115 — SV Spectrum MRC Central Venous Catheter; SV Spectrum MR Central Venous Catheter; (November 27, 2024)

Other clearances for product code LJS

  • K252792 — PM2™ System with ECGuide™ Connector (November 17, 2025)
  • K243458 — HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (700013 (August 1, 2025)
  • K251212 — Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr Hyd (July 1, 2025)
  • K243484 — PM2+ System and SmartPICC Stylet (May 29, 2025)
  • K241587 — pilot TLS (February 26, 2025)
  • K241910 — Neonav ECG Tip Location System (January 19, 2025)
  • K243941 — HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001 (January 17, 2025)
  • K240486 — PM2 System and ECGuide Connector (September 8, 2024)
  • K233149 — CATHTONG III Tapered PICC Catheter (December 1, 2023)
  • K230669 — L-Cath™ Single and Dual Lumen Catheters, L-Cath™ Midline Catheters (November 30, 2023)