PMA
P240004: EndoForce Connector for Endovascular Venous Anastomosis
FDA PMA · Covered stent vascular connector, hemodialysis access circuit · Phraxis, Inc.
Key facts
| PMA number | P240004 |
|---|---|
| Trade name | EndoForce Connector for Endovascular Venous Anastomosis |
| Generic name | Covered stent vascular connector, hemodialysis access circuit |
| Applicant | Phraxis, Inc. |
| Owner/operator | Phraxis Inc |
| Product code | SEQ |
| Approval date | May 15, 2025 |
| Establishment registration | 3014146191 |
| FEI number | 3014146191 |
At a glance
- 1–9 Supplements
- Jul 18, 2025 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 1–9 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: