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)

CARDIOVENTION POWERBASE CONSOLE, MODEL PBC-100

K-Number: K021694 · 2003-01-08

ApplicantCardiovention, Inc.
Decision Date2003-01-08
Product CodeDTQ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOVENTION POWERBASE CONSOLE, MODEL PBC-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 2003-01-08 under 510(k) number K021694. 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 CARDIOVENTION POWERBASE CONSOLE, MODEL PBC-100?

CARDIOVENTION POWERBASE CONSOLE, MODEL PBC-100 is a medical device that received FDA 510(k) clearance on 2003-01-08. The listed applicant is Cardiovention, Inc.. The 510(k) number is K021694.

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

CARDIOVENTION POWERBASE CONSOLE, MODEL PBC-100 received FDA 510(k) clearance on 2003-01-08, under 510(k) number K021694.

Who is the listed applicant for CARDIOVENTION POWERBASE CONSOLE, MODEL PBC-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 CARDIOVENTION POWERBASE CONSOLE, MODEL PBC-100?

The FDA product code for CARDIOVENTION POWERBASE CONSOLE, MODEL PBC-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.

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 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-200K030141MODIFICATION TO CARDIOVENTION POWERBASE CONSOLE, MODEL PCB-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

View on FDA Database →

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

↑