FDA 510(k)

THE COEUR INJECTOR ADAPTOR/PRESSURE JACKET, MODEL C859-6003

K-Number: K032920 · 2003-12-16

Decision Date2003-12-16

Product CodeDXT

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

THE COEUR INJECTOR ADAPTOR/PRESSURE JACKET, MODEL C859-6003 is the device name listed in this FDA 510(k) record. The listed applicant is Coeur Medical. It received FDA 510(k) clearance on 2003-12-16 under 510(k) number K032920. The device is classified under product code DXT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE COEUR INJECTOR ADAPTOR/PRESSURE JACKET, MODEL C859-6003?

THE COEUR INJECTOR ADAPTOR/PRESSURE JACKET, MODEL C859-6003 is a medical device that received FDA 510(k) clearance on 2003-12-16. The listed applicant is Coeur Medical. The 510(k) number is K032920.

When did THE COEUR INJECTOR ADAPTOR/PRESSURE JACKET, MODEL C859-6003 receive FDA 510(k) clearance?

THE COEUR INJECTOR ADAPTOR/PRESSURE JACKET, MODEL C859-6003 received FDA 510(k) clearance on 2003-12-16, under 510(k) number K032920.

Who is the listed applicant for THE COEUR INJECTOR ADAPTOR/PRESSURE JACKET, MODEL C859-6003?

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

What is the FDA product code for THE COEUR INJECTOR ADAPTOR/PRESSURE JACKET, MODEL C859-6003?

The FDA product code for THE COEUR INJECTOR ADAPTOR/PRESSURE JACKET, MODEL C859-6003 is DXT.

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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.