FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Ruby XL System
K Number: K250079
·
Decision Mar 14, 2025
Classifications
1
FEI Numbers
96
Registration Numbers
96
Same Product Code
122
Applicant Total
50
Review Days
60
Basic Information
- Device Name
- Ruby XL System
- K Number
- K250079
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.3300
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Penumbra, Inc.
- Date Received
- January 13, 2025
- Decision Date
- March 14, 2025
- Product Code
- KRD
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KRD | Device, Vascular, For Promoting Embolization | FDA class 2 | Cardiovascular |
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