K231646
- 510(k) number
- K231646
- Device name
- Carilex VT¿200-i NX
- Applicant
- Carilex Medical, Inc. TW
- Product code
- OMP — Negative Pressure Wound Therapy Powered Suction Pump
- Decision date
- 2024-04-17
- Date received
- 2023-06-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K231646.pdf
Official FDA record: K231646
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.