Home / 510(k) Clearances / K880027

510(k) K880027

CHURCHILL 1.2 MICRON LIQUID FILTER SET by Churchill Corp. — Product Code FPB

K880027 is an FDA 510(k) premarket notification submitted by Churchill Corp. for the device "CHURCHILL 1.2 MICRON LIQUID FILTER SET". The FDA issued a decision of Substantially Equivalent on April 13, 1988. The device falls under product code FPB (Filter, Infusion Line), a Class II device regulated under 21 CFR 880.5440. Churchill Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 13, 1988
Date Received
January 5, 1988
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 Corp.

  • K880025 — CHURCHILL 0.22 MICRON LIQUID FILTER SETS (April 14, 1988)
  • K880051 — ENTERAL BAG/SET (April 14, 1988)
  • K880026 — CHURCHILL 0.22 MICRON LIQUID COMPACT FILTER SETS (April 14, 1988)
  • K870395 — CHURCHILL PARENTERAL NUTRITION BAG - EVA (October 15, 1987)
  • K872585 — CHURCHILL-CATH (October 15, 1987)
  • K872124 — CHURCHILL ALBUMIN IV ADMINISTRATION SET (October 13, 1987)
  • K872123 — CHURCHILL TPN ADMINISTRATION SET (October 9, 1987)
  • K872043 — CHURCHILL INTER-CARDIAC SUCKER (September 30, 1987)
  • K871084 — NITROGLYCERINE PUMP SET (July 16, 1987)
  • K871732 — CHURCHILL-H VENTED IV SET W/METERING CHAMBERS (June 15, 1987)

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)
  • 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)
  • K941628 — 40 MICRON BLOOD TRANSFUSION FILTER (February 16, 1995)

FDA data resources