EndoForce Connector for Endovascular Venous Anastomosis
FDA premarket approval P240004/S002 · decided 2025-07-10
Approval details
- PMA number
- P240004
- Supplement
- S002
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- EndoForce Connector for Endovascular Venous Anastomosis
- Generic name
- Covered stent vascular connector, hemodialysis access circuit
- Applicant
- Phraxis, Inc.
- Date received
- 2025-06-12
- Decision date
- 2025-07-10
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- SEQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- implementation of changes to the Austenite finish (Af) temperature specification for the Nitinol Connector Frame of the EndoForce Connector for Endovascular Venous Anastomosis
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.