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510(k) K874491

IVAC(R) SITE-SAVER(R) VOLUMETRIC CONTROLLER - 280+ by Y — Product Code LDR

K874491 is an FDA 510(k) premarket notification submitted by Y for the device "IVAC(R) SITE-SAVER(R) VOLUMETRIC CONTROLLER - 280+". The FDA issued a decision of Substantially Equivalent on February 25, 1988. The device falls under product code LDR (Controller, Infusion, Intravascular, Electronic), a Class II device regulated under 21 CFR 880.5725. Y has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 25, 1988
Date Received
November 2, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Controller, Infusion, Intravascular, Electronic
Device Class
Class II
Regulation Number
880.5725
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)
  • K953225 — IVAC BALL VALCE ADMIN. SETS (September 27, 1995)
  • 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)

Other clearances for product code LDR

  • K242693 — DEKA Infusion System, DEKA Administration Set (October 7, 2024)
  • K232316 — DEKA Infusion System, DEKA Administration Set (March 1, 2024)
  • K153760 — Volumetric Infusion Controller (October 3, 2016)
  • K963136 — PACER MODEL 100 INFUSION CONTROLLER (October 10, 1997)
  • K971865 — ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M12/500-3P (July 3, 1997)
  • K971826 — ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M12/500 (July 3, 1997)
  • K934543 — UNIVERSAL CONTROLLER, MODEL 100 (March 29, 1994)
  • K935236 — FLOW CONTROLLING EXTENSION SET (February 24, 1994)
  • K905498 — STAT 2 IV PUMPETTE (April 16, 1991)
  • K905497 — MASTER FLOW I.V. PUMPETTE (April 16, 1991)

FDA data resources