FDA device listing

Vitalcor, Inc.

FDA device listing 1615362536 · Vitalcor, Inc.

Key facts

Proprietary names Vitalcor, Inc.
Owner/operator Vitalcor, Inc.
Owner/operator number 1450019
Product codes FHQ
Device names FHQ - Holder, Needle, Gastroenterologic
Device class Class I
Classification regulations (21 CFR) 876.4730
Review panels Gastroenterology & Urology
Registered establishments VITALCOR, INC.
Establishment registrations 1450019
FEI numbers 1450019
Establishment operations Specification Developer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • None listed 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

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