EndoForce Connector for Endovascular Venous Anastomosis
PMA P240004
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP240004 | Date15 May 2025 | StatusActive |
Recalls
No FDA recalls found in the data synced 26 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Generic Name
- Covered stent vascular connector, hemodialysis access circuit
- PMA Number
- FDA Product Code
- SEQ
- Device Class
- Class III
- Advisory Committee
- Cardiovascular
- FDA Decision
- APPR Approved
Overview
AI-generated summary, 18 Sep 2026
The EndoForce Connector is a covered stent vascular connector designed for hemodialysis access circuits. It provides an endovascular method to attach an arteriovenous graft to a vein in the upper arm, facilitating vascular access for hemodialysis in patients with end-stage renal disease. This device is classified as a Class III medical device under FDA regulations and is intended for use in conjunction with conventional suturing techniques during graft implantation.
The EndoForce Connector is supplied sterile and intended for single-use. It is approved for use in the upper arm and must be implanted by a trained healthcare professional in a controlled clinical setting. The device is regulated under FDA’s Premarket Approval (PMA) process, with approval granted under PMA number P240004. Compliance with sterility, sizing, and surgical application guidelines is critical for safe and effective use.
Other devices from Phraxis, Inc.
Questions
AI-generated answers, 18 Sep 2026
What is the EndoForce Connector specifically designed to do in a hemodialysis patient’s procedure?
The EndoForce Connector is designed to provide an endovascular method for attaching an arteriovenous graft to a vein in the upper arm, creating a stable vascular access site for hemodialysis. It works alongside conventional suturing of the graft to the artery during implantation, ensuring the graft can be used reliably for repeated dialysis sessions.
Is the EndoForce Connector reusable, or is it intended for single-use only?
The EndoForce Connector is explicitly intended for single-use only, as stated in its specifications. This ensures sterility and safety for each patient procedure, reducing the risk of contamination or device degradation between uses.
How is the EndoForce Connector supplied, and what precautions should be taken during handling?
The EndoForce Connector is supplied sterile, which means it is pre-packaged and ready for immediate use in a controlled clinical setting. To maintain sterility, it should be handled using aseptic techniques, avoiding contamination before implantation, and only opened in a sterile field by trained healthcare professionals.
What regulatory pathway was followed for the approval of the EndoForce Connector, and what does this mean for clinicians?
The EndoForce Connector was approved through the FDA’s Premarket Approval (PMA) process, which is the most stringent regulatory pathway for Class III medical devices. This means the device has undergone rigorous clinical evaluation to ensure safety and effectiveness, and clinicians can rely on its approved indications for use in endovascular venous anastomosis during hemodialysis access procedures.