K252373 is an FDA 510(k) clearance for the BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology. This device is classified as a Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (Class II - Special Controls, product code LJS).
Submitted by Spectrum Vascular (White Plains, US). The FDA issued a Cleared decision on December 16, 2025, 139 days after receiving the submission on July 30, 2025.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5970.
| 510(k) Number | K252373 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 30, 2025 |
| Decision Date | December 16, 2025 |
| Days to Decision | 139 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | LJS - Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5970 |