Ld-Six Arterial Blood Filter for Extra. Service

• • Terminated Z-2856-2011 FDA Unclassified (pre-2012) ·initiated 26 May 2011 ·on shared 510(k) K902518

  Potential for the housing of the arterial line Leukocyte Reduction Filter to separate before or during the priming procedure.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K902518 ↗

FDA Product Code

DTM

Device Class

Class II

Regulation

21 CFR Part 870.4260

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Pall Hepchek (Tm) Heparin Absorption Filter

  Class II

  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

  Class II

  FDA 510(k) K960993 Active Cleared 22 Apr 1996

• Posidyne Solution Container Filter, Recorder #96

  Class II

  FDA 510(k) K850826 Active Cleared 9 Apr 1985

• 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. →