Sterile Protective Sleeve W/Tough-Borst

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K822290 ↗

FDA Product Code

DQO

Device Class

Class II

Regulation

21 CFR Part 870.1200

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Umi (Franseen, Westcott, Greene, Menghini)Bio. Needle

  Not classified

  FDA 510(k) K860168 Active Cleared 19 Feb 1986

• Amnio Centeses Kit W/Needle

  Class I

  FDA 510(k) K830019 Active Cleared 18 Jan 1983

• Umi Steerable Torque Guide Wire

  Class II

  FDA 510(k) K863178 Active Cleared 19 Sep 1986

• Nice Pack

  Class I

  FDA 510(k) K832193 Active Cleared 31 Aug 1983

• Umi Cath-Seal, 13+14F & Transseptal Catheter Intro

  Class II

  FDA 510(k) K861984 Active Cleared 5 Aug 1986

• Umi Curved Chemonucleolysis Needle

  Class II

  FDA 510(k) K842012 Active Cleared 6 Jul 1984

See all devices from Universal Medical Instrument Corp. →