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510(k) K874405

PALL STAT PRIME(TM) BLOOD FILTER FOR EXTRA. USE by Pall Biomedical Products Co. — Product Code JOD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 30, 1987
Date Received
October 28, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4270
Review Panel
CV
Submission Type

Other clearances by Pall Biomedical Products Co.

  • K954331 — PALL LEA FILTER (LIPID EMULSION FILTER) (I.V. FILTER) (January 9, 1997)
  • K960993 — PALL SQ40S BLOOD FILTER (SQ40S/SQ40ST) (April 22, 1996)
  • K905794 — PALL 3N1 FILTER (June 13, 1991)
  • K902518 — LD-SIX ARTERIAL BLOOD FILTER FOR EXTRA. SERVICE (October 16, 1990)
  • K884534 — PALL HEPCHEK (TM) HEPARIN ABSORPTION FILTER (January 24, 1989)
  • K875095 — PALL CARDIOPLEGIA PLUS FILTER W/POSIDYNE MEMBRANE (February 29, 1988)
  • K875094 — ULTIPOR PRE-BYPASS PLUS FILTER W/POSIDYNE MEMBRANE (February 29, 1988)
  • K873667 — PALL LEUKOCYTE REMOVAL FILTER, PLATELETS (January 6, 1988)
  • K873666 — PALL LEUKOCYTE REMOVAL FILTER, BLOOD (January 6, 1988)
  • K853987 — PALL EC PLUS 3LPM MAX. FILTER W/SLEEVE (December 11, 1985)

Other clearances for product code JOD

  • K993060 — GAS FILTER (March 28, 2000)
  • K890504 — CARDIOTOMY/AUTOTRANSFUSION/PLEURAL DRAINAGE VENOUS (March 10, 1989)
  • K875095 — PALL CARDIOPLEGIA PLUS FILTER W/POSIDYNE MEMBRANE (February 29, 1988)
  • K855067 — SWANK CARDIOTOMY SUCTION LINE BLOOD FILTER CA100 (February 26, 1986)
  • K841958 — CARDIO METRICS CARDIOTOMY RESERVOIR (October 15, 1984)
  • K830634 — CARDIOTOMY FILTER (June 30, 1983)
  • K823259 — INTERFACE CARDIOTOMY BLOOD FILTER #50 (November 24, 1982)
  • K823260 — INTERFACE CARDIOTOMY BLOOD FILTER #51 (November 24, 1982)
  • K812243 — INTERFACE CARDIOTOMY BLOOD FILTER #51 (August 25, 1981)
  • K781383 — INTERFACE CARDIOTOMY BLOOD FILTER (September 27, 1978)