# Nova Vascular LLC (specification developer, New York, NY): 2 new FDA device listings, incl. introducer, catheter

**Score:** 70/100

| Field | Value |
|---|---|
| Establishment | Nova Vascular LLC |
| Role | Specification developer (outsources manufacturing) |
| Establishment types | Develop Specifications But Do Not Manufacture At This Facility |
| Location | New York, NY, US |
| New listings | 2 |
| Devices | Introducer, Catheter |
| Product codes | DYB |
| Device classes | Class II |
| Medical specialties | Cardiovascular |
| Brand names | NovaSeal; NovaSheath |
| First new listing | 2026-08-04 |
| Latest new listing | 2026-08-13 |
| FDA registration number | 3034300126 |
| Registration expires | 2026-12-31 |

## Why this score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
- U.S. establishment.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-10-28T20:51:27.468Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.