Ruby Intravascular Catheter— 510(k) K260432
Substantially EquivalentVenocare, Inc.
FDA 510(k) clearance K260432 for Ruby Intravascular Catheter, Substantially Equivalent on 2026-09-02. Applicant: Venocare, Inc.. Device class: 2.
Summary
Ruby Intravascular Catheter is from Venocare, Inc., filed under product code FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days). The record doesn't describe the catheter beyond its name and code.
Class II, 21 CFR 880.5200. General Hospital is both the classification panel and the review panel, and it came in as a Traditional 510(k). The decision was Substantially Equivalent.
Venocare filed from Doral, Florida. The decision came 203 calendar days after FDA received it (February 11 to September 2, 2026).
Clearance details
- Applicant
- Venocare, Inc.
- Product code
- Product code FOZ
- Device class
- Class 2
- Regulation
- 21 CFR 880.5200
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Doral, FL, US
Recent devices under product code FOZ
view allMore clearances from Venocare, Inc.
view allAdverse events under product code FOZ
product code FOZ- Death
- 38
- Injury
- 2,290
- Malfunction
- 25,858
- Other
- 11
- Total
- 28,197
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.