FDA 510(k)

TRUCATH.IP

K-Number: K023368 · 2002-10-28

Decision Date2002-10-28

Product CodeDFG

Advisory CommitteeIM

DecisionSubstantially Equivalent

Device Summary

TRUCATH.IP is the device name listed in this FDA 510(k) record. The listed applicant is Aortech Critical Care , Ltd.. It received FDA 510(k) clearance on 2002-10-28 under 510(k) number K023368. The device is classified under product code DFG. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRUCATH.IP?

TRUCATH.IP is a medical device that received FDA 510(k) clearance on 2002-10-28. The listed applicant is Aortech Critical Care , Ltd.. The 510(k) number is K023368.

When did TRUCATH.IP receive FDA 510(k) clearance?

TRUCATH.IP received FDA 510(k) clearance on 2002-10-28, under 510(k) number K023368.

Who is the listed applicant for TRUCATH.IP?

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

What is the FDA product code for TRUCATH.IP?

The FDA product code for TRUCATH.IP is DFG.

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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.