Endospan , Ltd.: FDA clearances and approvals
Endospan , Ltd. 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 5 device clinical trials on ClinicalTrials.gov.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| SDZ | Endovascular System For Treatment Of Ascending Aorta And Aortic Arch Lesions | 1 | 0 |
Review panels
- Cardiovascular (1)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P250033 | PMA | NEXUS Aortic Arch Stent Graft System | 2026-04-02 |
Recalls
openFDA lists no recalls under a recalling firm named Endospan , Ltd..
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
Endospan , Ltd. is the industry lead sponsor of 5 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT04471909: NEXUS Aortic Arch Clinical Study to Evaluate Safety and Effectiveness (Recruiting, started 2020-10-20)
- NCT03420066: The NEXUS™ Compassionate Use Data Collection Study (Completed, started 2018-02-19)
- NCT03208504: The Single Branch NEXUS™ Clinical Study (Completed, started 2017-11-27)
- NCT02365454: NEXUS™ Aortic Arch Stent Graft System First In Man Study (Completed, started 2014-08)
- NCT02087501: HORIZON CE Pivotal Study to Treat Abdominal Aortic Aneurysm (Completed, started 2014-04)
Frequently asked questions
How many FDA 510(k) clearances does Endospan , Ltd. have?
Endospan , Ltd. has 0 FDA 510(k) clearances, plus 1 PMA decision, across 1 product code in 1 review panel.
What devices does Endospan , Ltd. make?
Its most frequent FDA product codes are SDZ (Endovascular System For Treatment Of Ascending Aorta And Aortic Arch Lesions, 1).
Has Endospan , Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Endospan , Ltd. Related entities may recall under other names.
Next steps
- See all 0 Endospan , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code SDZ, Endospan , Ltd.'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.