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FDA 510(k)

MODIFICATION TO CARDIOVENTION POWERBASE CONSOLE, MODEL PCB-100

K-Number: K030141 · 2003-02-26

ApplicantCardiovention, Inc.
Decision Date2003-02-26
Product CodeDTQ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO CARDIOVENTION POWERBASE CONSOLE, MODEL PCB-100 is the device name listed in this FDA 510(k) record. The listed applicant is Cardiovention, Inc.. It received FDA 510(k) clearance on 2003-02-26 under 510(k) number K030141. The device is classified under product code DTQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO CARDIOVENTION POWERBASE CONSOLE, MODEL PCB-100?

MODIFICATION TO CARDIOVENTION POWERBASE CONSOLE, MODEL PCB-100 is a medical device that received FDA 510(k) clearance on 2003-02-26. The listed applicant is Cardiovention, Inc.. The 510(k) number is K030141.

When did MODIFICATION TO CARDIOVENTION POWERBASE CONSOLE, MODEL PCB-100 receive FDA 510(k) clearance?

MODIFICATION TO CARDIOVENTION POWERBASE CONSOLE, MODEL PCB-100 received FDA 510(k) clearance on 2003-02-26, under 510(k) number K030141.

Who is the listed applicant for MODIFICATION TO CARDIOVENTION POWERBASE CONSOLE, MODEL PCB-100?

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

What is the FDA product code for MODIFICATION TO CARDIOVENTION POWERBASE CONSOLE, MODEL PCB-100?

The FDA product code for MODIFICATION TO CARDIOVENTION POWERBASE CONSOLE, MODEL PCB-100 is DTQ.

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.

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Other records listing Cardiovention, 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.

K032068CARDIOVENTION CORX IOS-200 SYSTEM, MODEL IOS-200K021694CARDIOVENTION POWERBASE CONSOLE, MODEL PBC-100K012325CARDIOVENTION CORX SYSTEM, MODEL FG 0001

Related Devices (Code: DTQ)

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.

K232291Essenz HLM, Essenz ILBMLivanova Deutschland, GmbHK221895Terumo Advanced Perfusion System 1Terumo Cardiovascular Systems CorporationK221373Essenz HLMLivanova Deutschland, GmbHK210130Stockert S5 SystemLivanova Deutschland, GmbHK202125Century Perfusion SystemCentury Hlm, LLCK190282Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand)Spectrum Medical , Ltd.

Official Source

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

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