Entera-Flo Spike Set

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K893209 ↗

FDA Product Code

KNT

Device Class

Class II

Regulation

21 CFR Part 876.5980

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Enteral Pump Set W/Entera-Flo Spike

  Class II

  FDA 510(k) K895650 Active Cleared 2 Oct 1990

• Intertech Sterile Water for Inhalation

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• Delmed 80/2 Dialysis System W/Last Bag Option

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• Empty Transfer Bag

  Class II

  FDA 510(k) K791673 Active Cleared 23 Oct 1979

• Albumin Intravenous Administration Set

  Class II

  FDA 510(k) K791672 Active Cleared 26 Oct 1979

• Hospal Dialysate for C.A.V.H.D.

  Class II

  FDA 510(k) K872857 Active Cleared 5 Oct 1987

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