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)

CARDIOMAX-II

K-Number: K861543 · 1987-03-10

ApplicantColumbus Instruments Intl. Corp.
Decision Date1987-03-10
Product CodeDXG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOMAX-II is the device name listed in this FDA 510(k) record. The listed applicant is Columbus Instruments Intl. Corp.. It received FDA 510(k) clearance on 1987-03-10 under 510(k) number K861543. The device is classified under product code DXG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIOMAX-II?

CARDIOMAX-II is a medical device that received FDA 510(k) clearance on 1987-03-10. The listed applicant is Columbus Instruments Intl. Corp.. The 510(k) number is K861543.

When did CARDIOMAX-II receive FDA 510(k) clearance?

CARDIOMAX-II received FDA 510(k) clearance on 1987-03-10, under 510(k) number K861543.

Who is the listed applicant for CARDIOMAX-II?

The FDA 510(k) record lists Columbus Instruments Intl. Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CARDIOMAX-II?

The FDA product code for CARDIOMAX-II is DXG.

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 Columbus Instruments Intl. 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.

K895791OXYMAXK861100ISO-THERMEXK782036TREMOR MONITORK771718CARDIOTHERM-500X

Related Devices (Code: DXG)

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.

K253092Argos Infinity (Rev. 1.0)Retia Medical Systems, Inc.K251275VitalStream ART Connect; VitalStream-HemoCaretaker MedicalK232048Cogent™ Hemodynamic Monitoring System; Cogent™ HMSIcu MedicalK212529Hypotension Decision Assist Model HDA-OR2Directed Systems, Ltd.K192169PulsioFlex Monitoring System with ProAQT SensorPulsion Medical Systems SEK193179EV1000 Clinical PlatformEdwards Lifesciences, LLC

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.

↑