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FDA 510(k)

CARDEON AEGIS CATHETER

K-Number: K013593 · 2002-06-24

ApplicantCardeon Corp.
Decision Date2002-06-24
Product CodeDWF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDEON AEGIS CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Cardeon Corp.. It received FDA 510(k) clearance on 2002-06-24 under 510(k) number K013593. The device is classified under product code DWF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDEON AEGIS CATHETER?

CARDEON AEGIS CATHETER is a medical device that received FDA 510(k) clearance on 2002-06-24. The listed applicant is Cardeon Corp.. The 510(k) number is K013593.

When did CARDEON AEGIS CATHETER receive FDA 510(k) clearance?

CARDEON AEGIS CATHETER received FDA 510(k) clearance on 2002-06-24, under 510(k) number K013593.

Who is the listed applicant for CARDEON AEGIS CATHETER?

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

What is the FDA product code for CARDEON AEGIS CATHETER?

The FDA product code for CARDEON AEGIS CATHETER is DWF.

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 Cardeon 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.

K042156CARDEON COBRA CATHETERK024058MODIFICATION TO CARDEON AEGIS CATHETERK022042MODIFICATION TO CARDEON ASCENDING BALLOON CANNULA (ABC)K022174MODIFICATION TO CARDEON AEGIS CATHETERK001371CARDEON ASCENDING BALLOON CANNULA (ABC)

Related Devices (Code: DWF)

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.

K260195Elongated One-Piece Arterial (EOPA) 3D™ Arterial CannulaeMedtronic, Inc.K250937Venous Return CannulaeLivaNova USA, Inc.K260043Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C)Smart ReactorsK253203Retrograde Coronary Sinus Perfusion CannulaeMedtronic, Inc.K253671Dual Stage Venous CannulaeSorin Group Italia S.R.L.K253998Clearview Intracoronary ShuntsMedtronic, Inc.

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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