FDA device listing

DEKA TAC Device

FDA device listing 1244937112 · DEKA Research & Development Corp.

Key facts

Proprietary names DEKA TAC Device
Owner/operator DEKA Research & Development Corp.
Owner/operator number 10041884
Premarket submissions K093915
Product codes FIG
Device names FIG - Clamp, Tubing, Blood, Automatic
Device class Class II
Classification regulations (21 CFR) 876.5820
Review panels Gastroenterology & Urology
Registered establishments DEKA RESEARCH & DEVELOPMENT CORP.
Establishment registrations 1220973
FEI numbers 1220973
Establishment operations Specification Developer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • None 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

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