FDA 510(k)

CREATION NM DIAGNOSTIC CATHETERS

K-Number: K032888 · 2004-02-24

ApplicantNeich Medical (Shenzhen) Company Limited

Decision Date2004-02-24

Product CodeDQO

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

CREATION NM DIAGNOSTIC CATHETERS is the device name listed in this FDA 510(k) record. The listed applicant is Neich Medical (Shenzhen) Company Limited. It received FDA 510(k) clearance on 2004-02-24 under 510(k) number K032888. The device is classified under product code DQO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CREATION NM DIAGNOSTIC CATHETERS?

CREATION NM DIAGNOSTIC CATHETERS is a medical device that received FDA 510(k) clearance on 2004-02-24. The listed applicant is Neich Medical (Shenzhen) Company Limited. The 510(k) number is K032888.

When did CREATION NM DIAGNOSTIC CATHETERS receive FDA 510(k) clearance?

CREATION NM DIAGNOSTIC CATHETERS received FDA 510(k) clearance on 2004-02-24, under 510(k) number K032888.

Who is the listed applicant for CREATION NM DIAGNOSTIC CATHETERS?

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

What is the FDA product code for CREATION NM DIAGNOSTIC CATHETERS?

The FDA product code for CREATION NM DIAGNOSTIC CATHETERS is DQO.

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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.