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FDA 510(k)

COAXIA FLOCONTROL CATHETER

K-Number: K023914 · 2003-02-21

ApplicantCoaxia, Inc.
Decision Date2003-02-21
Product CodeMJN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

COAXIA FLOCONTROL CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Coaxia, Inc.. It received FDA 510(k) clearance on 2003-02-21 under 510(k) number K023914. The device is classified under product code MJN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COAXIA FLOCONTROL CATHETER?

COAXIA FLOCONTROL CATHETER is a medical device that received FDA 510(k) clearance on 2003-02-21. The listed applicant is Coaxia, Inc.. The 510(k) number is K023914.

When did COAXIA FLOCONTROL CATHETER receive FDA 510(k) clearance?

COAXIA FLOCONTROL CATHETER received FDA 510(k) clearance on 2003-02-21, under 510(k) number K023914.

Who is the listed applicant for COAXIA FLOCONTROL CATHETER?

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

What is the FDA product code for COAXIA FLOCONTROL CATHETER?

The FDA product code for COAXIA FLOCONTROL CATHETER is MJN.

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 Coaxia, 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.

K090970FLOCONTROL , MODEL 1028

Related Devices (Code: MJN)

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.

K243795pREBOA-PRO CatheterPrytime Medical Devices, Inc.K251358Bridge Plus Occlusion Balloon (590-002)Philips Image Guided Therapy DevicesK221294preCARDIA Occlusion SystemAbiomed, Inc.K214060LANDMARK REBOA CatheterZien Medical Technologies, Inc.K211610Fogarty Occlusion CatheterEdwards Lifesciences, LLCK212324RenovoCathRenovorx, 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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