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510(k) K013949

UNIVERSAL VIAL ACCESS SPIKE WITH NEEDLELESS CONNECTOR by Churchill Medical Systems, Inc. — Product Code FPA

K013949 is an FDA 510(k) premarket notification submitted by Churchill Medical Systems, Inc. for the device "UNIVERSAL VIAL ACCESS SPIKE WITH NEEDLELESS CONNECTOR". The FDA issued a decision of Substantially Equivalent on March 27, 2002. The device falls under product code FPA (Set, Administration, Intravascular), 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
March 27, 2002
Date Received
November 30, 2001
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 Medical Systems, Inc.

  • K041038 — CHURCHILL MEDICAL DUAL CHAMBER EMPTY CONTAINER (December 21, 2004)
  • K021395 — MODIFICATION TO 30 EXTENSION SET (May 13, 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)
  • K894954 — .22 & 1.2 MICRON IV FILTERS (November 13, 1989)
  • K884370 — CMS IV EXTENSION SETS (November 7, 1988)

Other clearances for product code FPA

  • K254123 — Ecomed Disposable Administration Sets (September 11, 2026)
  • 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)

FDA data resources