Data / Medical devices / United States / Ellipsys Medical, Inc.
Ellipsys Medical, Inc.: FDA-registered device maker in San Clemente, CA, United States, 1 510(k) clearance
Ellipsys Medical, Inc. is registered with the FDA (registration 3045323126) in San Clemente, CA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated August 9, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3045323126
- Address
- 990 Calle Negocio, San Clemente, CA, United States, 92673
- Owner or operator
- Ellipsys Medical (10095750)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- April 23, 2026
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access | PQK | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 9, 2019 | K191114 | Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Needle | PQK | Substantially Equivalent | Avenu Medical | accessdata.fda.gov |
Compare with other makers
- All makers of Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access
Updated August 9, 2019. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.