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510(k) K001762

PULSION CONTINUOUS PULSE CONTOUR CARDIAC OUTPUT (PICCO) SYSTEM by Pulsion Medical Systems, Inc. — Product Code DXG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 13, 2000
Date Received
June 9, 2000
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 Pulsion Medical Systems, Inc.

  • K112448 — PULSIOFLEX (September 22, 2011)
  • K091786 — PULSION PICCO2 (8500), CEVOX OPTICAL MODULE (PC3015), CEVOX DISPOSABLE PROBES ( (June 18, 2010)
  • K072735 — PULSION PICCO-2, MODEL 8500 (October 18, 2007)
  • K072364 — PULSION PULSIOCATH THERMODILUTION CATHETERS & ACCESSORIES (September 19, 2007)
  • K060898 — PULSION PICCO PLUS, MODEL 8100 (July 25, 2006)
  • K020587 — PULSION PULSIOCATH PICCO MONITORING KIT, INJECTATE SENSOR TEMPERATURE HOUSING PV (May 23, 2002)
  • K991886 — PULSION PULSIOCATH, PULSION PCCO MONITORING KIT, PULSION IN-LINE INJECTATE SENSO (May 11, 2000)

Other clearances for product code DXG

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  • 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)