Cornaris Intravascular Imaging System (P80-E); Cornaris Intravascular Imaging System (Mobile-E); LumenCross Imaging Catheter (F2)— 510(k) K242098
Substantially EquivalentShenzhen Vivolight Medical Device & Technology Co., Ltd.
FDA 510(k) clearance K242098 for Cornaris Intravascular Imaging System (P80-E); Cornaris Intravascular Imaging System (Mobile-E); LumenCross Imaging Catheter (F2), Substantially Equivalent on 2025-04-11. Applicant: Shenzhen Vivolight Medical Device & Technology Co., Ltd..
Clearance details
- Applicant
- Shenzhen Vivolight Medical Device & Technology Co., Ltd.
- Product code
- Code NQQ
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shenzhen, CN
Data sourced from openFDA. This site is unofficial and independent of the FDA.