BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology and PASV Valve T
Summary
Spectrum Vascular received 510(k) clearance for 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, a LJS device. Cleared on 2025-12-16.
Details
Source
510(k) Clearance
External ID
K252373
Action Date
2025-12-16
Status
Traditional
Category
device
Product Code
LJS
Product Description
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. Product code: LJS.
Company
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 403 device clearances issued this month. Spectrum Vascular has received 4 total clearances in our database.
Spectrum Vascular has 4 FDA actions in our database, including 4 clearances.
Frequently Asked Questions
What does 510(k) clearance mean?
A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.
How often does Spectrum Vascular have FDA actions?
Spectrum Vascular has 4 FDA actions in our database, including 0 recalls and 4 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K252373" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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