K232234
- 510(k) number
- K232234
- Device name
- Nouvo Safety Set
- Applicant
- Poly Medicure Limited IN
- Product code
- FOZ — Catheter, Intravascular, Therapeutic, Short-Term Les
- Decision date
- 2024-03-15
- Date received
- 2023-07-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
510(k) Summary (official FDA PDF): K232234.pdf
Official FDA record: K232234
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.