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510(k) K894111

VARI-SET by Sonex Medical — Product Code LDR

K894111 is an FDA 510(k) premarket notification submitted by Sonex Medical for the device "VARI-SET". The FDA issued a decision of Substantially Equivalent on September 28, 1989. The device falls under product code LDR (Controller, Infusion, Intravascular, Electronic), a Class II device regulated under 21 CFR 880.5725.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 28, 1989
Date Received
June 12, 1989
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

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  • 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)
  • K905497 — MASTER FLOW I.V. PUMPETTE (April 16, 1991)
  • K905498 — STAT 2 IV PUMPETTE (April 16, 1991)

FDA data resources