FDA 510(k)

FFRangio

K-Number: K192442 · 2019-12-09

Decision Date2019-12-09

Product CodeQEK

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

FFRangio is the device name listed in this FDA 510(k) record. The listed applicant is Cathworks, Ltd.. It received FDA 510(k) clearance on 2019-12-09 under 510(k) number K192442. The device is classified under product code QEK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FFRangio?

FFRangio is a medical device that received FDA 510(k) clearance on 2019-12-09. The listed applicant is Cathworks, Ltd.. The 510(k) number is K192442.

When did FFRangio receive FDA 510(k) clearance?

FFRangio received FDA 510(k) clearance on 2019-12-09, under 510(k) number K192442.

Who is the listed applicant for FFRangio?

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

What is the FDA product code for FFRangio?

The FDA product code for FFRangio is QEK.

Other records listing Cathworks, Ltd. 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.

K182149FFRangio System

Related Devices (Code: QEK)

K182149FFRangio SystemCathworks, Ltd.

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.