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510(k) K861430

CHURCHILL INJECTION SITE by Churchill Corp. — Product Code FPA

K861430 is an FDA 510(k) premarket notification submitted by Churchill Corp. for the device "CHURCHILL INJECTION SITE". The FDA issued a decision of Substantially Equivalent on May 12, 1986. The device falls under product code FPA (Set, Administration, Intravascular), 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
May 12, 1986
Date Received
April 16, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Administration, Intravascular
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)
  • K880026 — CHURCHILL 0.22 MICRON LIQUID COMPACT FILTER SETS (April 14, 1988)
  • K880051 — ENTERAL BAG/SET (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 FPA

  • K261530 — iiSure Infusion Set (June 3, 2026)
  • K252543 — AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, (May 4, 2026)
  • K251375 — PuraCath Firefly Needleless Connector IT (9005) (February 12, 2026)
  • K251257 — nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Fre (December 4, 2025)
  • K250325 — BD Alaris Pump Infusion Set (October 30, 2025)
  • K251814 — EZ™ IV Administration Set (August 29, 2025)
  • K251854 — SteadiSet infusion set (August 6, 2025)
  • K243841 — Sparta Infusion Set for Insulin (August 1, 2025)
  • K243392 — Infusomat® Space Volumetric Infusion Pump Administration Sets (July 24, 2025)
  • K250616 — Clave™ Neutral-Displacement Needlefree Connectors (June 5, 2025)

FDA data resources