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FDA 510(k)

MODIFICATION TO CARDEON AEGIS CATHETER

K-Number: K022174 · 2002-07-29

ApplicantCardeon Corp.
Decision Date2002-07-29
Product CodeDWF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO 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 2002-07-29 under 510(k) number K022174. 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 MODIFICATION TO CARDEON AEGIS CATHETER?

MODIFICATION TO CARDEON AEGIS CATHETER is a medical device that received FDA 510(k) clearance on 2002-07-29. The listed applicant is Cardeon Corp.. The 510(k) number is K022174.

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

MODIFICATION TO CARDEON AEGIS CATHETER received FDA 510(k) clearance on 2002-07-29, under 510(k) number K022174.

Who is the listed applicant for MODIFICATION TO 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 MODIFICATION TO CARDEON AEGIS CATHETER?

The FDA product code for MODIFICATION TO 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.

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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)K013593CARDEON 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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