FDA device listing

Mitral Valve Repair Devices

FDA device listing 1788382713 · Cordica Medical (Formally Team Technologies, Inc)

Key facts

Owner/operator Cordica Medical (Formally Team Technologies, Inc)
Owner/operator number 1051594
Product codes NKM
Device names NKM - Mitral Valve Repair Devices
Device class Class III
Classification regulations (21 CFR) ORCA1.NKM
Review panels Cardiovascular
Registered establishments CORDICA MEDICAL, INC. (Formally TEAM Technologies, Inc.)
Establishment registrations 3015807001
FEI numbers 3015807001
Establishment operations U.S. Manufacturer of Export Only Devices
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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