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510(k) K993379

PALL SUPOR AEF FILTER by Pall Corp. — Product Code FPB

K993379 is an FDA 510(k) premarket notification submitted by Pall Corp. for the device "PALL SUPOR AEF FILTER". The FDA issued a decision of Substantially Equivalent on December 16, 1999. The device falls under product code FPB (Filter, Infusion Line), a Class II device regulated under 21 CFR 880.5440. Pall Corp. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 1999
Date Received
October 7, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filter, Infusion Line
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

Other clearances by Pall Corp.

  • K022167 — PALL DONER PRE-EVACUATED POST-OPERATIVE AUTOLOGOUS BLOOD REINFUSION SYSTEM (March 7, 2003)
  • K980762 — PALL STAT-PRIME D BLOOD FILTER FOR EXTRACORPOREAL SERVICE (September 1, 1998)

Other clearances for product code FPB

  • K233277 — Filter Needle for Single Use (May 10, 2024)
  • K143583 — Cathivex ¿GV filter units (August 11, 2015)
  • K113227 — NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTER (December 8, 2011)
  • K021293 — ARTERIA BLOOD FILTER (August 22, 2002)
  • K974661 — 0.2 U BACTERIAL FILTER (February 11, 1998)
  • K964283 — AUTOPRIME (January 22, 1997)
  • K954331 — PALL LEA FILTER (LIPID EMULSION FILTER) (I.V. FILTER) (January 9, 1997)
  • K933523 — I.V. FILTER SET (May 19, 1995)
  • K941628 — 40 MICRON BLOOD TRANSFUSION FILTER (February 16, 1995)
  • K942625 — 1.2 MICRON AIR ELIMINATING FILTER (October 7, 1994)

FDA data resources