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510(k) K171620

PiCCO Catheter by Pulsion Medical Systems SE — Product Code KRB

K171620 is an FDA 510(k) premarket notification submitted by Pulsion Medical Systems SE for the device "PiCCO Catheter". The FDA issued a decision of Substantially Equivalent on February 21, 2018. The device falls under product code KRB (Probe, Thermodilution), a Class II device regulated under 21 CFR 870.1915. Pulsion Medical Systems SE has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 2018
Date Received
June 2, 2017
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 SE

  • K192169 — PulsioFlex Monitoring System with ProAQT Sensor (April 30, 2020)
  • K172259 — PulsioFlex Monitoring System (January 18, 2018)
  • K122121 — PULSIOFLEX MONITORING SYSTEM WITH PICCO MODULE (August 2, 2012)

Other clearances for product code KRB

  • 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)
  • K991886 — PULSION PULSIOCATH, PULSION PCCO MONITORING KIT, PULSION IN-LINE INJECTATE SENSO (May 11, 2000)
  • 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)

FDA data resources