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FDA 510(k)

CARDEON ASCENDING BALLOON CANNULA (ABC)

K-Number: K001371 · 2000-07-07

ApplicantCardeon Corp.
Decision Date2000-07-07
Product CodeDWF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDEON ASCENDING BALLOON CANNULA (ABC) is the device name listed in this FDA 510(k) record. The listed applicant is Cardeon Corp.. It received FDA 510(k) clearance on 2000-07-07 under 510(k) number K001371. 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 ASCENDING BALLOON CANNULA (ABC)?

CARDEON ASCENDING BALLOON CANNULA (ABC) is a medical device that received FDA 510(k) clearance on 2000-07-07. The listed applicant is Cardeon Corp.. The 510(k) number is K001371.

When did CARDEON ASCENDING BALLOON CANNULA (ABC) receive FDA 510(k) clearance?

CARDEON ASCENDING BALLOON CANNULA (ABC) received FDA 510(k) clearance on 2000-07-07, under 510(k) number K001371.

Who is the listed applicant for CARDEON ASCENDING BALLOON CANNULA (ABC)?

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 ASCENDING BALLOON CANNULA (ABC)?

The FDA product code for CARDEON ASCENDING BALLOON CANNULA (ABC) 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 CATHETERK013593CARDEON AEGIS CATHETER

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

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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