510(k) clearance
Ruby Intravascular Catheter
- 510(k) number
- K260432
- Applicant
- Venocare, Inc.
- Decision date
- Sep 2, 2026
- Date received
- Feb 11, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- FOZ
- Device type
- Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- Device class
- Class II
- Regulation
- 21 CFR 880.5200
- Advisory committee
- General Hospital
- Statement or summary
- Summary
- Third party
- N
- Location
- Doral, FL, US