Data / Medical devices / United States / Vesalio
Vesalio: FDA-registered device maker in San Diego, CA, United States, 5 510(k) clearances
Vesalio is registered with the FDA (registration 3014498720) in San Diego, CA, United States. It lists 8 device types. The FDA files 5 510(k) clearances under its listings, the newest dated January 6, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014498720
- Address
- 2305 Historic Decatur Rd Suite 100, San Diego, CA, United States, 92106
- Owner or operator
- Vesalio, Inc (10057432)
- Roles
- Complaint file establishment, Manufacturer, Manufacturer for export, Specification developer
- First device listed
- April 6, 2018
- Registered through
- 2026
- Brand names listed
- NeVa M1, NeVa M1-S, NeVa M1-Sx, NeVa M1x, NeVa T, NeVa Tx, NeVa VS, NeVa VSx and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Aspiration Thrombectomy Catheter | QEZ | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Catheter, Continuous Flush | KRA | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Catheter, Percutaneous | DQY | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Catheter, Percutaneous, Neurovasculature | QJP | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Catheter, Thrombus Retriever | NRY | 2 | Complaint file establishment, Manufacturer for export, Specification developer | accessdata.fda.gov |
| Coronary Mechanical Thrombectomy With Aspiration | QEX | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Peripheral Mechanical Thrombectomy With Aspiration | QEW | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Temporary Percutaneous Transluminal Cerebral Artery Dilatation Device | QTK | f | Complaint file establishment, Manufacturer, Specification developer | 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 |
|---|---|---|---|---|---|---|
| January 6, 2026 | K251097 | V-DAC Catheter | QJP | Substantially Equivalent | Vesalio, Inc. | accessdata.fda.gov |
| November 24, 2025 | K253407 | NeVa PV Thrombectomy Device | QEX | Unknown | Vesalio, Inc. | accessdata.fda.gov |
| November 10, 2025 | K251006 | NeVasc Aspiration System | NRY | Substantially Equivalent | Vesalio, Inc. | accessdata.fda.gov |
| October 24, 2025 | K251312 | Vesalio Peripheral System | QEZ | Substantially Equivalent | Vesalio, Inc. | accessdata.fda.gov |
| January 15, 2021 | K201085 | NeVa PV Thrombectomy Device | QEW | Substantially Equivalent | Vesalio | accessdata.fda.gov |
Compare with other makers
- All makers of Catheter, Thrombus Retriever
- All makers of Coronary Mechanical Thrombectomy With Aspiration
- All makers of Aspiration Thrombectomy Catheter
- All makers of Catheter, Percutaneous
- All makers of Catheter, Percutaneous, Neurovasculature
- All makers of Peripheral Mechanical Thrombectomy With Aspiration
Updated January 6, 2026. 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.