Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

TERUMO KHURI MYOCARDIAL PH MONITORING SYSTEM

K-Number: K020967 · 2002-06-20

ApplicantTerumo Cardiovascular Systems Corp.
Decision Date2002-06-20
Product CodeCBZ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

TERUMO KHURI MYOCARDIAL PH MONITORING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Terumo Cardiovascular Systems Corp.. It received FDA 510(k) clearance on 2002-06-20 under 510(k) number K020967. The device is classified under product code CBZ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TERUMO KHURI MYOCARDIAL PH MONITORING SYSTEM?

TERUMO KHURI MYOCARDIAL PH MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 2002-06-20. The listed applicant is Terumo Cardiovascular Systems Corp.. The 510(k) number is K020967.

When did TERUMO KHURI MYOCARDIAL PH MONITORING SYSTEM receive FDA 510(k) clearance?

TERUMO KHURI MYOCARDIAL PH MONITORING SYSTEM received FDA 510(k) clearance on 2002-06-20, under 510(k) number K020967.

Who is the listed applicant for TERUMO KHURI MYOCARDIAL PH MONITORING SYSTEM?

The FDA 510(k) record lists Terumo Cardiovascular Systems Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TERUMO KHURI MYOCARDIAL PH MONITORING SYSTEM?

The FDA product code for TERUMO KHURI MYOCARDIAL PH MONITORING SYSTEM is CBZ.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Terumo Cardiovascular Systems Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K130333CAPIX RX HOLLOW FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIRK130359CAPIOX SX18 HOLLOW FIBER OXYGENATOR WITH DETACHABLE HARDSHELL RESERVOIR, CAPIOX SX25 HOLLOW FIBER OXGENATOR WITH DETACHAK123039CDI BLOOD PARAMETER MONITORING SYSTEM 500K113214TLINK DATA MANAGEMENT SYSTEM (DMS)K112587ADVANCED PERFUSION SYSTEM 1 (APS1) TUBE CLAMP ASSEMBLY, ROLLER PUMP 6 INCH CLASSIC COLOR,K092789VIRTUOSAPH PLUS ENDOSCOPIC VESSEL HARVESTING SYSTEM

View all 38 devices →

Related Devices (Code: CBZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K970906PARATREND 7 MULTIPARAMETER SENIOR AND SATELLITE MONITOR SYSTEM WITH PARATREND 7 PLUS MULTIPARAMETER SENSORDiametrics Medical, Ltd.K931112MODEL PB3300 INTRA-ARTER BLOOD GAS MONIT SYS, MODIPuritan Bennett Corp.K920061HEMOMETRIX CONTINUOUS BLOOD GAS MONITORING SYSTEMAbbott LaboratoriesK912030CDI(TM) 2000 BLOOD GAS MONITORING SYST, MODIFIED3M CompanyK912428PB3300 SENSING CATHETER FOR CONTINUOUS MEASUREMENTPuritan Bennett Corp.K884228CDI(R) 2000 BLOOD GAS MONITORCardiovascular Devices, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑