Phraxis, Inc.: FDA clearances and approvals
Phraxis, Inc. has 0 FDA 510(k) clearances, plus 1 PMA decision, across 1 product code in 1 review panel. It is the industry lead sponsor of 2 device clinical trials on ClinicalTrials.gov.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| SEQ | Covered Stent Vascular Connector, Hemodialysis Access Circuit | 1 | 0 |
Review panels
- Cardiovascular (1)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P240004 | PMA | EndoForce Connector for Endovascular Venous Anastomosis | 2025-05-15 |
Recalls
openFDA lists no recalls under a recalling firm named Phraxis, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
Phraxis, Inc. is the industry lead sponsor of 2 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT05448950: Continued Access Study VIG Anastomotic Connector (Completed, started 2022-06-07)
- NCT02532621: Clinical Evaluation of a Vascular Venous Anastomotic Connector [InterGraft VIG-only Study] (Completed, started 2018-02-21)
Frequently asked questions
How many FDA 510(k) clearances does Phraxis, Inc. have?
Phraxis, Inc. has 0 FDA 510(k) clearances, plus 1 PMA decision, across 1 product code in 1 review panel.
What devices does Phraxis, Inc. make?
Its most frequent FDA product codes are SEQ (Covered Stent Vascular Connector, Hemodialysis Access Circuit, 1).
Has Phraxis, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Phraxis, Inc. Related entities may recall under other names.
Next steps
- See all 0 Phraxis, Inc. clearances with predicates and recalls
- Run predicate analysis for product code SEQ, Phraxis, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.