Product code

LBJ: Device, vein stabilization

FDA product code · Class I · General Hospital

Key facts

Product code LBJ
Device Device, vein stabilization
Device class Class I
Regulation number 880.6980
Review panel General Hospital
Medical specialty General Hospital
Submission type 510(K) Exempt
GMP exempt Yes

At a glance

  • None 510(k) clearances
  • None De Novo grants
  • None PMA approvals
  • None HDE approvals
  • None UDI devices (GUDID)
  • None MAUDE adverse event reports
  • 1–9 Recalled products (Z-numbers)

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

About FDA device product codes

FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.

Source: U.S. Food and Drug Administration (FDA), Product Classification database

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