Pall 3N1 Filter

• • Terminated Z-2715-2011 FDA Unclassified (pre-2012) ·initiated 15 Jun 2011

  Incorrect filter media used (0.2 um filter used instead of the required 1.2 um) within the TNA1 filter used with total parenteral nutrition mixtures.

510(k) Number

K905794 ↗

FDA Product Code

FPB

Device Class

Class II

Regulation

21 CFR Part 880.5440

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Pall Hepchek (Tm) Heparin Absorption Filter

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  FDA 510(k) K884534 Active Cleared 24 Jan 1989

• Ultipor Solution Container Filter

  Class II

  FDA 510(k) K790879 Active Cleared 1 Jun 1979

• Pall SQ40S Blood Filter (SQ40S/SQ40ST) Open recall

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  FDA 510(k) K960993 Active Cleared 22 Apr 1996

• Posidyne Solution Container Filter, Recorder #96

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• Pall Pulmonary Function Filter

  Class II

  FDA 510(k) K854062 Active Cleared 7 Nov 1985

• Ultipor SQ40S Blood Transfusion Filter

  Class II

  FDA 510(k) K811985 Active Cleared 28 Jul 1981

See all devices from Pall Biomedical Products Co. →