Home / 510(k) Clearances / K852060

510(k) K852060

INFUSION SETS MODELS 9120,9121,9125, 9122 & 9123 by Cardiac Pacemakers, Inc. — Product Code FRN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 7, 1985
Date Received
May 9, 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 Cardiac Pacemakers, Inc.

  • K093969 — ACUITY BREAK-AWAY GUIDE CATHETER (March 5, 2010)
  • K080154 — ACUITY UNIVERSAL CUTTER (March 20, 2008)
  • K934727 — REPLACEMENT PARTS FOR CPI 6888 LEAD TUNNELER (January 10, 1994)
  • K920601 — ASTRA T2, ASTRA T4, ASTRA T6 (October 28, 1992)
  • K912379 — PDT CARRYALL TRANSMITTER, VARIOUS MODELS (June 17, 1991)
  • K905674 — LEAD STYLET (January 30, 1991)
  • K900498 — MODIFIED BETATRON IV INSULIN INFUSION SYSTEM (February 23, 1990)
  • K894738 — MODEL 6888 LEAD TUNNELER (September 13, 1989)
  • K890785 — ASTRA T2, T3, T4, T6 PULSE GENERATORS NEW PACKAGE (March 10, 1989)
  • K875147 — TORQUE HEX WRENCH (January 27, 1988)

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)