Venclose digiRF Generator with Maven Catheter, Venclose Maven System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by Venclose Inc
Identifiers
- 510(k) Number
- K211806 FDA 510(k)
- FDA Product Code
- GEI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4400 FDA 510(k)
- Regulation Number
- 878.4400 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Venclose Maven System is a radiofrequency (RF) energy-based device designed for tissue ablation and closure of venous insufficiency lesions. It combines a generator and a specialized catheter to deliver controlled thermal energy for the treatment of varicose veins and related vascular conditions.
The system is supplied as a sterile, single-use device intended for use in clinical settings by trained medical professionals. The Venclose digiRF Generator powers the Maven Catheter, which is inserted percutaneously to target and ablate affected venous tissue. The device is classified under product code GEI (General and Plastic Surgery Devices) and has received FDA 510(k) clearance and MDD authorization. Proper storage and handling are required to maintain sterility and functionality.
Frequently asked questions
What types of venous conditions is the Venclose Maven System intended to treat, and how does it work?
The Venclose Maven System is designed specifically for treating venous insufficiency lesions, such as varicose veins and related vascular conditions. It works by delivering controlled radiofrequency (RF) energy through the Maven Catheter, which is inserted percutaneously to target and ablate affected venous tissue. The RF energy generates thermal energy to close and seal the veins, reducing symptoms like swelling, pain, and cosmetic concerns.
Is the Venclose Maven System reusable, or is it meant for single-use only? How should it be stored to maintain sterility?
The Venclose Maven System is supplied as a sterile, single-use device, meaning each component (the digiRF Generator and Maven Catheter) is intended for one procedure only. To maintain sterility, it should be stored in its original packaging, away from direct sunlight, extreme temperatures, and moisture, following the manufacturer’s instructions. Proper storage ensures the device remains functional and safe for clinical use.
What are the key differences between the Venclose digiRF Generator and the Maven Catheter in the system?
The Venclose digiRF Generator is the power source that delivers controlled radiofrequency energy, while the Maven Catheter is the disposable, sterile component inserted into the vein to apply that energy. Together, they form the Venclose Maven System, where the generator powers the catheter to perform tissue ablation and vein closure. The catheter is single-use, while the generator may be reused for multiple procedures (if compatible with manufacturer guidelines).
How do I know if the Venclose Maven System is appropriate for my practice, and what regulatory approvals does it have?
The Venclose Maven System is classified under product code GEI (General and Plastic Surgery Devices) and has received FDA 510(k) clearance (K211806) and MDD authorization, confirming its compliance with U.S. and European regulatory standards. It is intended for use in clinical settings by trained medical professionals to treat venous insufficiency. If your practice specializes in vascular or cosmetic vein treatments, this system may align with your offerings—verify compatibility with your facility’s existing equipment and staff training.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K211806 | Class II | Active |
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Manufacturer
- Manufacturer
- Venclose Inc
- FDA Applicant
- Venclose, Inc.
Sources (2)
- FDA 510(k) K211806 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 29, 2026