Data / Medical devices / United States / Nova Vascular LLC
Nova Vascular LLC: FDA-registered device maker in New York, NY, United States, 2 510(k) clearances
Nova Vascular LLC is registered with the FDA (registration 3034300126) in New York, NY, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated October 21, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3034300126
- Address
- 99 Wall St # 878, New York, NY, United States, 10005
- Owner or operator
- Nova Vascular LLC (10093640)
- Roles
- Specification developer
- First device listed
- June 16, 2025
- Registered through
- 2026
- Brand names listed
- NovaBalloon, NovaSeal, NovaSheath
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Balloon Type | GBA | 1 | Specification developer | accessdata.fda.gov |
| Introducer, Catheter | DYB | 2 | 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 |
|---|---|---|---|---|---|---|
| October 21, 2025 | K251838 | Introducer Sheath Set | DYB | Substantially Equivalent | Cardiocycle Medical(Suzhou) Co., Ltd. | accessdata.fda.gov |
| August 22, 2024 | K242248 | Introducer Sheath Kits | DYB | Substantially Equivalent | Beijing Demax Medical Technology Co.,Ltd | accessdata.fda.gov |
Compare with other makers
Updated October 21, 2025. 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.