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510(k) K834106

INTRAVENOUS INFUSION CONTROLLER by Cutter Laboratories, Inc. — Product Code LDR

K834106 is an FDA 510(k) premarket notification submitted by Cutter Laboratories, Inc. for the device "INTRAVENOUS INFUSION CONTROLLER". The FDA issued a decision of Substantially Equivalent on May 30, 1984. The device falls under product code LDR (Controller, Infusion, Intravascular, Electronic), a Class II device regulated under 21 CFR 880.5725. Cutter Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 30, 1984
Date Received
November 29, 1983
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 Cutter Laboratories, Inc.

  • K861315 — HYPERBARIC PENETRATION EXTENSION SET (May 21, 1986)
  • K854106 — BAYSILEX (March 17, 1986)
  • K842324 — PERFOURM (November 9, 1984)
  • K832237 — ORTHOPEDIC CASTING TAPE MAXCAST (August 16, 1983)
  • K823214 — DOSIMETRIC RELEASE PROGRAM - ADMIN. SET (January 12, 1983)
  • K821326 — CUTTER BOND POLYCARBOXYLATE CEMENT (May 28, 1982)
  • K813532 — CUTTERBOND ZINC PHOSPHATE CEMENT (March 2, 1982)
  • K802105 — C-BLADE (September 16, 1980)
  • K802104 — C-SPLINT (September 16, 1980)
  • K801652 — TOTAL PARENTERAL NUTRITION SET BAG (August 27, 1980)

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