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510(k) K020967

TERUMO KHURI MYOCARDIAL PH MONITORING SYSTEM by Terumo Cardiovascular Systems Corp. — Product Code CBZ

K020967 is an FDA 510(k) premarket notification submitted by Terumo Cardiovascular Systems Corp. for the device "TERUMO KHURI MYOCARDIAL PH MONITORING SYSTEM". The FDA issued a decision of Substantially Equivalent on June 20, 2002. The device falls under product code CBZ (Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling), a Class II device regulated under 21 CFR 868.1170. Terumo Cardiovascular Systems Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 2002
Date Received
March 25, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling
Device Class
Class II
Regulation Number
868.1170
Review Panel
AN
Submission Type

Other clearances by Terumo Cardiovascular Systems Corp.

  • K153140 — Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir, Terumo Capiox SX18 Oxygenato (December 2, 2015)
  • K133658 — CDI BLOOD PARAMETER MONITORING SYSTEM 500 (July 25, 2014)
  • K131041 — ADVANCED PERFUSION SYSTEM 1 (February 20, 2014)
  • K132451 — SARNS SOFT-FLOW AORTIC CANNULA (February 18, 2014)
  • K133151 — SARNS HIGH FLOW AORTIC ARCH CANNULA (February 3, 2014)
  • K130333 — CAPIX RX HOLLOW FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR (March 13, 2013)
  • K130359 — CAPIOX SX18 HOLLOW FIBER OXYGENATOR WITH DETACHABLE HARDSHELL RESERVOIR, CAPIOX (March 13, 2013)
  • K123039 — CDI BLOOD PARAMETER MONITORING SYSTEM 500 (November 20, 2012)
  • K113214 — TLINK DATA MANAGEMENT SYSTEM (DMS) (February 7, 2012)
  • K112587 — ADVANCED PERFUSION SYSTEM 1 (APS1) TUBE CLAMP ASSEMBLY, ROLLER PUMP 6 INCH CLASS (December 19, 2011)

Other clearances for product code CBZ

  • K970906 — PARATREND 7 MULTIPARAMETER SENIOR AND SATELLITE MONITOR SYSTEM WITH PARATREND 7 (September 23, 1997)
  • K931112 — MODEL PB3300 INTRA-ARTER BLOOD GAS MONIT SYS, MODI (June 1, 1993)
  • K920061 — HEMOMETRIX CONTINUOUS BLOOD GAS MONITORING SYSTEM (March 30, 1992)
  • K912030 — CDI(TM) 2000 BLOOD GAS MONITORING SYST, MODIFIED (October 30, 1991)
  • K912428 — PB3300 SENSING CATHETER FOR CONTINUOUS MEASUREMENT (August 9, 1991)
  • K884228 — CDI(R) 2000 BLOOD GAS MONITOR (January 30, 1989)
  • K862114 — KHURI REGIONAL TISSUE PH MONITOR (June 25, 1986)
  • K803260 — SENSOMAT MUSCLE/TISSUE PH (February 2, 1981)
  • K803014 — SENSOMAT (December 22, 1980)

FDA data resources