Winged & Subcutaneous Infusion Sets

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K955709 ↗

FDA Product Code

FPA

Device Class

Class II

Regulation

21 CFR Part 880.5440

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Minibore Stopcock Set

  Class II

  FDA 510(k) K954984 Active Cleared 23 Jan 1996

• Vented Solution Set

  Class II

  FDA 510(k) K955732 Active Cleared 21 Feb 1996

• Core-Resistant Huber Infusion Set with Y-Site

  Class II

  FDA 510(k) K950597 Active Cleared 26 Jul 1995

• Intravascular Administration Set

  Class II

  FDA 510(k) K945184 Active Cleared 8 Feb 1995

• 60 Micro Volume Extension Set W/.22 Micron Filter, 21 Extension Set W/1.2 Mivton Gilyrt, Inj. Site, Clamp

  Class II

  FDA 510(k) K952663 Active Cleared 14 Jul 1995

• Extension Set with Check Valve

  Class II

  FDA 510(k) K954983 Active Cleared 23 Jan 1996

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