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510(k) K953225

IVAC BALL VALCE ADMIN. SETS by Y — Product Code FPA

K953225 is an FDA 510(k) premarket notification submitted by Y for the device "IVAC BALL VALCE ADMIN. SETS". The FDA issued a decision of Substantially Equivalent on September 27, 1995. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Y has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 1995
Date Received
July 10, 1995
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 Y

  • K955846 — MODEL 2082 TEMP PLUS III THERMOMETER/MODEL 2087 TEMP PLUS III WALL MOUNT THERMOM (October 1, 1996)
  • K960280 — IVAC NEEDLE FREE VALVE ADMINISTRATION SETS (April 4, 1996)
  • K934095 — IVAC VENTED SYRINGE ADAPTER ADMINISTRATION SETS (August 10, 1994)
  • K940897 — IVAC NEEDLELESS INFECTION VALVE ADMINISTRATION SET (June 22, 1994)
  • K931550 — EZ ADMINISTRATION SET (January 10, 1994)
  • K931549 — MODEL EZ-1 SING CHAN/EZ-2 DUAL CHANNEL INFUS PUMP (October 12, 1993)
  • K922115 — IVAC NEEDLELESS INJECTION VALVE (October 12, 1993)
  • K932544 — IVAC SPACE SAVER VOLUMETRIC PUMP, MODEL 599 (October 12, 1993)
  • K930781 — INFUSION PUMP (August 19, 1993)
  • K925228 — IVAC 59 SERIES UNIVERSAL SET W/ ANTI-FREE FLOW VAL (July 30, 1993)

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