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510(k) K991886

PULSION PULSIOCATH, PULSION PCCO MONITORING KIT, PULSION IN-LINE INJECTATE SENSOR by Pulsion Medical Systems, Inc. — Product Code KRB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 11, 2000
Date Received
June 2, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Probe, Thermodilution
Device Class
Class II
Regulation Number
870.1915
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)
  • K001762 — PULSION CONTINUOUS PULSE CONTOUR CARDIAC OUTPUT (PICCO) SYSTEM (June 13, 2000)

Other clearances for product code KRB

  • K171620 — PiCCO Catheter (February 21, 2018)
  • K100739 — VOLUMEVIEW SYSTEM, MODELS VLV520FT6R, VLV520FT8R, VLV520FT6R5 (December 7, 2010)
  • K072364 — PULSION PULSIOCATH THERMODILUTION CATHETERS & ACCESSORIES (September 19, 2007)
  • K020587 — PULSION PULSIOCATH PICCO MONITORING KIT, INJECTATE SENSOR TEMPERATURE HOUSING PV (May 23, 2002)
  • K936182 — CRITIKIT PLUS IN LINE ROOM/ICE TEMPERATURE INJECTATE KIT (March 25, 1994)
  • K915627 — PACEVIEW (March 27, 1992)
  • K912172 — SAFEWEDGE(TM) RELIEF VALVE DEVICE (September 27, 1991)
  • K902627 — INTERFLO MEDICAL MODEL OXI/CO FILA. THERMO. CATH. (February 25, 1991)
  • K900710 — INTERFLO MEDICAL MODEL F-1 THERMODILUTION CATHETER (October 19, 1990)
  • K900317 — PACEMATE FLOW DIRECTED THERMAL DILUTION CATHETER (June 22, 1990)