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everlinQ endoAVF System

by Tva Medical, Inc.

De Novo DEN160006

Active United States

De Novo

Valid until

No expiry

De Novo grant is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA De Novo, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA De NovoDENG De Novo granted · Direct NumberDEN160006 Date22 Jun 2018DecidedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA De Novo Active

Specification

De Novo

De Novo Number
FDA Product Code
PQK
Device Class
Class II
Regulation
21 CFR Part 870.1252
Advisory Committee
Cardiovascular
FDA Decision
DENG De Novo granted

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The everlinQ endoAVF System is a Percutaneous Catheter for Creation of an Arteriovenous Fistula for Hemodialysis Access, classified under FDA regulation 870.1252. This device is designed to facilitate the formation of arteriovenous fistulas (AVFs) in the vascular system, enabling reliable hemodialysis access for patients with end-stage renal disease. It combines endovascular techniques with specialized catheter technology to create a durable vascular connection.

The system is supplied as a sterile, single-use device and is intended for use in interventional radiology or vascular access procedures. It is available in a 6F configuration and must be used exclusively with the components specified in the labeling to ensure proper function. The device is regulated under FDA 510(k) clearance (K-number: DEN160006) and adheres to cardiovascular medical specialty standards. Storage and handling follow standard sterile medical device protocols.

Other devices from Tva Medical, Inc.

Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the everlinQ endoAVF System specifically designed to create and why is this important for patients?

    The everlinQ endoAVF System is designed to create arteriovenous fistulas (AVFs) in the vascular system using a percutaneous catheter approach. This is important because AVFs provide a reliable, long-term access route for hemodialysis, which is critical for patients with end-stage renal disease who require regular blood purification treatments. The system combines endovascular techniques with specialized catheter technology to establish a durable vascular connection, reducing the need for repeated catheter insertions or grafts.

  • Is the everlinQ endoAVF System intended for reuse or is it meant to be used only once per patient?

    The everlinQ endoAVF System is supplied as a sterile, single-use device. This design ensures patient safety by preventing cross-contamination between procedures, which is a standard practice for percutaneous catheters used in vascular access. Each system is intended for one-time use in creating an AVF for hemodialysis access.

  • What size configuration is available for the everlinQ endoAVF System, and are there any restrictions on compatible components?

    The everlinQ endoAVF System is available exclusively in a 6 French (6F) configuration. To ensure proper function and safety, the device must be used exclusively with the components specified in its labeling. This means only the manufacturer-approved accessories and tools should be utilized during the procedure.

  • How should the everlinQ endoAVF System be stored, and what precautions should be taken?

    The everlinQ endoAVF System follows standard sterile medical device protocols for storage and handling. Since it is sterile and single-use, it should be stored in its original packaging in a clean, dry environment, protected from physical damage and contamination. Proper storage ensures sterility is maintained until use, adhering to best practices for percutaneous catheters in interventional radiology or vascular access procedures.

  • What type of regulatory clearance does the everlinQ endoAVF System hold, and under which FDA classification is it categorized?

    The everlinQ endoAVF System holds FDA 510(k) clearance under the classification Percutaneous Catheter for Creation of an Arteriovenous Fistula for Hemodialysis Access (FDA regulation 870.1252). This clearance was granted through a direct submission to the FDA’s Cardiovascular (CV) advisory committee, with the K-number DEN160006. The device adheres to cardiovascular medical specialty standards.