FDA device listing

Tourniquet, Pneumatic

FDA device listing 1146972121 · Alphapointe

Key facts

Owner/operator Alphapointe
Owner/operator number 10046233
Product codes KCY
Device names KCY - Tourniquet, Pneumatic
Device class Class I
Classification regulations (21 CFR) 878.5910
Review panels General & Plastic Surgery
Registered establishments Alphapointe
Establishment registrations 3010759902
FEI numbers 3010759902
Establishment operations Manufacturer
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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