Home / 510(k) Clearances / K850674

510(k) K850674

CORMED II AMBULATORY INFUSION PUMP by Cormed, Inc., Sub. C.R.Bard, Inc. — Product Code FRN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 9, 1985
Date Received
February 20, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Infusion
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type

Other clearances by Cormed, Inc., Sub. C.R.Bard, Inc.

  • K863606 — BUTTERFLY NON-CORING NEEDLE SET (December 18, 1986)
  • K860432 — PERCUTANEOUS INTRODUCER KIT (March 31, 1986)
  • K854019 — PORT-GARD (November 26, 1985)
  • K850967 — STERILE CORMED MEDIPORT (May 17, 1985)
  • K843083 — CORMED HUBER POINT NEEDLE (September 5, 1984)
  • K833915 — VASCULAR ACCESS CATH. REPAIR KIT (March 30, 1984)
  • K823553 — CORCATH H & B VASCULAR ACCESS CATHETER (January 5, 1983)

Other clearances for product code FRN

  • K252015 — FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubin (January 28, 2026)
  • K251636 — Spectrum IQ Infusion System with Dose IQ Safety Software (3570009) (July 28, 2025)
  • K251640 — SIGMA Spectrum Infusion Pump with Master Drug Library (July 28, 2025)
  • K242752 — MRidium 3870 MRI Infusion Pump System (3870) (May 28, 2025)
  • K243855 — BD Alaris Infusion System with Guardrails Suite MX (April 25, 2025)
  • K242115 — Plum Duo™ Precision IV Pump (April 2, 2025)
  • K242114 — Plum Solo™ Precision IV Pump (April 2, 2025)
  • K250357 — RemunityPRO™ Pump for Remodulin® (treprostinil) Injection (March 11, 2025)
  • K241736 — Remunity 2.0 Pump for Remodulin (treprostinil) Injection (January 16, 2025)
  • K242735 — Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 1000 ml/min); Belmont Rapid Inf (December 23, 2024)