FDA device listing

VasoGuard

FDA device listing 1135493648 · Corvascular Diagnostics, LLC

Key facts

Proprietary names VasoGuard
Owner/operator Corvascular Diagnostics, LLC
Owner/operator number 10048428
Premarket submissions K233976
Product codes JOP
Device names JOP - Transducer, Ultrasonic
Device class Class II
Classification regulations (21 CFR) 870.2880
Review panels Cardiovascular
Registered establishments CORVASCULAR
Establishment registrations 3033275035
FEI numbers 3033275035
Establishment operations Manufacturer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • 10–99 UDI devices (GUDID) under the same submission
  • 1–9 Device listings citing the same submission
  • Yes Premarket submission listed

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device listings

Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.

Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database

Browse all FDA device listings