Home / 510(k) Clearances / K872529

510(k) K872529

THERMODILUTION CARDIAC OUTPUT COMPUTER, MOD. COM-2 by American Edwards Laboratories — Product Code DXG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 1987
Date Received
June 26, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Computer, Diagnostic, Pre-Programmed, Single-Function
Device Class
Class II
Regulation Number
870.1435
Review Panel
CV
Submission Type

Other clearances by American Edwards Laboratories

  • K873485 — EDSLAB (R) OCCLUSION BALLOON CATHETER (December 3, 1987)
  • K872596 — TRANTEC DISPOSABLE PRESSURE TRANS.53-600/F/F30 (September 30, 1987)
  • K870444 — HOMEPRO II VOLUMETRIC INFUSION PUMP (April 17, 1987)
  • K864997 — MEDTRAC VP VOLUMETRIC INFUSION PUMP (February 27, 1987)
  • K864330 — SHEAR FORCE GAUGE (January 6, 1987)
  • K862724 — VEIN VALVE CUTTER (January 2, 1987)
  • K863596 — CHIN-FOGARTY INFLATION DEVICE (November 20, 1986)
  • K864155 — MODIFICATION OF CARPENTIER-EDWARDS BIOPROSTHESIS (November 20, 1986)
  • K863986 — XENON LIGHT SOURCE FOR ENDOSCOPIC PROCEDURES (October 31, 1986)
  • K862872 — FLEXIBLE VISUALIZATION CATHETER (October 24, 1986)

Other clearances for product code DXG

  • K253092 — Argos Infinity (Rev. 1.0) (February 13, 2026)
  • K251275 — VitalStream ART Connect; VitalStream-Hemo (September 26, 2025)
  • K232048 — Cogent™ Hemodynamic Monitoring System; Cogent™ HMS (December 20, 2023)
  • K212529 — Hypotension Decision Assist Model HDA-OR2 (November 23, 2021)
  • K192169 — PulsioFlex Monitoring System with ProAQT Sensor (April 30, 2020)
  • K193179 — EV1000 Clinical Platform (December 17, 2019)
  • K190955 — Hypotension Decision Assist (November 27, 2019)
  • K181372 — Argos (December 13, 2018)
  • K172259 — PulsioFlex Monitoring System (January 18, 2018)
  • K163334 — LiDCOunity v2 Hemodynamic Monitor (June 5, 2017)