K243105
- 510(k) number
- K243105
- Device name
- Ruby Intravascular Catheter
- Applicant
- Venocare, Inc. FL · US
- Product code
- FOZ — Catheter, Intravascular, Therapeutic, Short-Term Les
- Decision date
- 2025-05-16
- Date received
- 2024-09-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K243105.pdf
Official FDA record: K243105
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.