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FDA 510(k)

TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEM

K-Number: K080116 · 2008-09-08

ApplicantTransonic Systems, Inc.
Decision Date2008-09-08
Product CodeDXG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Transonic Systems, Inc.. It received FDA 510(k) clearance on 2008-09-08 under 510(k) number K080116. 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 TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEM?

TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEM is a medical device that received FDA 510(k) clearance on 2008-09-08. The listed applicant is Transonic Systems, Inc.. The 510(k) number is K080116.

When did TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEM receive FDA 510(k) clearance?

TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEM received FDA 510(k) clearance on 2008-09-08, under 510(k) number K080116.

Who is the listed applicant for TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEM?

The FDA 510(k) record lists Transonic Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEM?

The FDA product code for TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEM is DXG.

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Other records listing Transonic Systems, Inc. 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.

K113821TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEMK112657AUREFLO MONITORING SYSTEMK033424ANGIOFLOW METER, ANGIOFLOW ANTEGRADE CATHETER, ANGIOFLOW RETROGRADE CATHETER, MODELS HVT100, ADT1001, ADT1002K022963TRANSONIC SYRINGE WARMER, MODEL SYR-1000K021571TRANSONIC FLOW-QC SET MODEL ADT1010K010253ANGIO FLOW THERMODILUTION CATHETER, MODEL AF-CATH-01; ANGIOFLOW METER, MODELS HQ100 AND HQ101

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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.

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