EndoForce Connector for Endovascular Venous Anastomosis
FDA premarket approval P240004 · decided 2025-05-15
Approval details
- PMA number
- P240004
- Trade name
- EndoForce Connector for Endovascular Venous Anastomosis
- Generic name
- Covered stent vascular connector, hemodialysis access circuit
- Applicant
- Phraxis, Inc.
- Date received
- 2024-03-08
- Decision date
- 2025-05-15
- Days to decision
- 433 days
- Decision code
- APPR
- Product code
- SEQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval for Phraxis, Inc. EndoForce Connector for Endovascular Venous Anastomosis. This device is indicated to provide an endovascular method for attachment of an arteriovenous graft to a vein in the upper arm in patients with end stage renal disease requiring hemodialysis. The EndoForce Connector is used together with conventional suturing of the graft to the artery during the implantation procedure. The graft is then used for vascular access during hemodialysis.
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