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510(k) K861626

CHURCHILL EXTENSION TUBE by Churchill Corp. — Product Code FPK

K861626 is an FDA 510(k) premarket notification submitted by Churchill Corp. for the device "CHURCHILL EXTENSION TUBE". The FDA issued a decision of Substantially Equivalent on June 2, 1986. The device falls under product code FPK (Tubing, Fluid Delivery), 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
June 2, 1986
Date Received
April 22, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubing, Fluid Delivery
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

Other clearances by Churchill Corp.

  • K880051 — ENTERAL BAG/SET (April 14, 1988)
  • K880025 — CHURCHILL 0.22 MICRON LIQUID FILTER SETS (April 14, 1988)
  • K880026 — CHURCHILL 0.22 MICRON LIQUID COMPACT FILTER SETS (April 14, 1988)
  • K880027 — CHURCHILL 1.2 MICRON LIQUID FILTER SET (April 13, 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)

Other clearances for product code FPK

  • K131517 — MEDRAD TWIST & GO HIGH PRESSURE CONNECTOR TUBING (August 2, 2013)
  • K063114 — DISPOSABLE TRANSFER SETS WITH AND WITHOUT SWABBABLE VALVES AND/OR CHECK VALVES (February 9, 2007)
  • K063239 — LIFESHIELD LATEX-FREE GRAVITECH FLOW CONTROLLER I.V. SETS, MODELS 17528, 17527, (December 11, 2006)
  • K052431 — MEDTRONIC MINIMED LEAPFROG II INFUSION SET, MODELS MMT-801S1, MMT-801L1, MMT-801 (November 29, 2005)
  • K041178 — EMPOWER TRANSFER SET, (CAT. NO. 7725) (July 16, 2004)
  • K031808 — MEDRAD SWABBABLE VALVE TRANSFER SET (July 11, 2003)
  • K022431 — MEDRAD TRANSFER SET (September 5, 2002)
  • K965208 — POLYFIN EXTENSION SET, MODELS 126 AND 128 (February 26, 1997)
  • K953864 — SILCLEAR TUBING (MODIFICATION) (November 6, 1995)
  • K950508 — SYSMEX SF-3000 (November 3, 1995)

FDA data resources