Tef/Platinum Piston

No FDA recalls found in the data synced 11 Oct 2026.

510(k) Number

K915120 ↗

FDA Product Code

ETB

Device Class

Class II

Regulation

21 CFR Part 874.3450

Advisory Committee

Ear, Nose, Throat

FDA Decision

SESE Substantially Equivalent

• PTFE Piston

  Class II

  FDA 510(k) K913285 Active Cleared 18 Dec 1991

• River Pump

  Class II

  FDA 510(k) K932895 Active Cleared 31 Mar 1994

• Smartdose IV Prefilled Infusion Container

  Class II

  FDA 510(k) K944351 Active Cleared 15 Nov 1995

• Smartdose III Infusion Container

  Class II

  FDA 510(k) K944352 Active Cleared 15 Nov 1995

• H/A Partial - Regular & H/a Partial - Offset

  Class II

  FDA 510(k) K913287 Active Cleared 18 Dec 1991

• Collar Button Style Venturi

  Class II

  FDA 510(k) K904594 Active Cleared 28 Jan 1991

See all devices from River Medical, Inc. →