FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TriSalus TriNav® LV Infusion System
K Number: K230957
·
Decision May 2, 2023
Classifications
1
FEI Numbers
147
Registration Numbers
147
Same Product Code
174
Applicant Total
3
Review Days
28
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Basic Information
- Device Name
- TriSalus TriNav® LV Infusion System
- K Number
- K230957
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1210
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Trisalus Life Sciences
- Date Received
- April 4, 2023
- Decision Date
- May 2, 2023
- Product Code
- KRA
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KRA | Catheter, Continuous Flush | FDA class 2 | Cardiovascular |
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