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FDA 510(k)

FLOCONTROL , MODEL 1028

K-Number: K090970 · 2009-06-12

ApplicantCoaxia, Inc.
Decision Date2009-06-12
Product CodeMJN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FLOCONTROL , MODEL 1028 is the device name listed in this FDA 510(k) record. The listed applicant is Coaxia, Inc.. It received FDA 510(k) clearance on 2009-06-12 under 510(k) number K090970. 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 FLOCONTROL , MODEL 1028?

FLOCONTROL , MODEL 1028 is a medical device that received FDA 510(k) clearance on 2009-06-12. The listed applicant is Coaxia, Inc.. The 510(k) number is K090970.

When did FLOCONTROL , MODEL 1028 receive FDA 510(k) clearance?

FLOCONTROL , MODEL 1028 received FDA 510(k) clearance on 2009-06-12, under 510(k) number K090970.

Who is the listed applicant for FLOCONTROL , MODEL 1028?

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 FLOCONTROL , MODEL 1028?

The FDA product code for FLOCONTROL , MODEL 1028 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.

K023914COAXIA FLOCONTROL CATHETER

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.

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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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