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510(k) K902627

INTERFLO MEDICAL MODEL OXI/CO FILA. THERMO. CATH. by Biometric Research Institute, Inc. — Product Code KRB

K902627 is an FDA 510(k) premarket notification submitted by Biometric Research Institute, Inc. for the device "INTERFLO MEDICAL MODEL OXI/CO FILA. THERMO. CATH.". The FDA issued a decision of Substantially Equivalent on February 25, 1991. The device falls under product code KRB (Probe, Thermodilution), a Class II device regulated under 21 CFR 870.1915. Biometric Research Institute, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 25, 1991
Date Received
June 13, 1990
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 Biometric Research Institute, Inc.

  • K902628 — INTERFLO MEDICAL MODEL INTERFLO/1 CARDIAC OUTPUT (February 25, 1991)

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)
  • 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)
  • K900710 — INTERFLO MEDICAL MODEL F-1 THERMODILUTION CATHETER (October 19, 1990)
  • K900317 — PACEMATE FLOW DIRECTED THERMAL DILUTION CATHETER (June 22, 1990)

FDA data resources