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510(k) K894954

.22 & 1.2 MICRON IV FILTERS by Churchill Medical Systems, Inc. — Product Code FPB

K894954 is an FDA 510(k) premarket notification submitted by Churchill Medical Systems, Inc. for the device ".22 & 1.2 MICRON IV FILTERS". The FDA issued a decision of Substantially Equivalent on November 13, 1989. The device falls under product code FPB (Filter, Infusion Line), a Class II device regulated under 21 CFR 880.5440. Churchill Medical Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 13, 1989
Date Received
August 4, 1989
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 Churchill Medical Systems, Inc.

  • K041038 — CHURCHILL MEDICAL DUAL CHAMBER EMPTY CONTAINER (December 21, 2004)
  • K021395 — MODIFICATION TO 30 EXTENSION SET (May 13, 2002)
  • K013949 — UNIVERSAL VIAL ACCESS SPIKE WITH NEEDLELESS CONNECTOR (March 27, 2002)
  • K020544 — WING SAFE INFUSION SET 20 GA, SHS2000 SERIES; WING SAFE INFUSION SET 19 GA, SHS1 (March 12, 2002)
  • K013950 — VENTED VIAL ACCESS DEVICE (January 10, 2002)
  • K012157 — CHURCHILL MEDICAL SYSTEMS STOPCOCK (September 11, 2001)
  • K011888 — PRESSURE ACTIVATED CHECK VALVE (September 10, 2001)
  • K011336 — PRIMARY SOLUTION SET WITH UNIVERSAL SPIKE, INJECTION SITE AND MALE LUER LOCK (June 12, 2001)
  • K896333 — CMS IV FILTERS (January 11, 1990)
  • K884370 — CMS IV EXTENSION SETS (November 7, 1988)

Other clearances for product code FPB

  • K261403 — Lipipor NLF1A Infusion Filter, Lipipor NLF2A & NLF2NTA Infusion Filters, Lipipor (August 31, 2026)
  • 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)
  • K993379 — PALL SUPOR AEF FILTER (December 16, 1999)
  • 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)

FDA data resources