FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
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
K Number: K252373
·
Decision Dec 16, 2025
Classifications
1
FEI Numbers
90
Registration Numbers
90
Same Product Code
301
Applicant Total
4
Review Days
139
Basic Information
- 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
- K Number
- K252373
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5970
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Spectrum Vascular
- Date Received
- July 30, 2025
- Decision Date
- December 16, 2025
- Product Code
- LJS
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | FDA class 2 | General Hospital |
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Other Clearances by Spectrum Vascular
| K Number | Device Name | ||
|---|---|---|---|
| K254278 | Arterial Pressure Monitoring Set/Tray | Mar 25, 2026 | Substantially Equivalent |
| K250724 | Intraosseous Infusion Needles | Jul 30, 2025 | Substantially Equivalent |
| K241115 | SV Spectrum MRC Central Venous Catheter; SV Spectrum MR Central Venous Catheter; SV Central Venous Catheter | Nov 27, 2024 | Substantially Equivalent |