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FDA 510(k)

VENOJECT LUER ADAPTER

K-Number: K041358 · 2004-05-28

ApplicantTerumo Europe N.V.
Decision Date2004-05-28
Product CodeJKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

VENOJECT LUER ADAPTER is the device name listed in this FDA 510(k) record. The listed applicant is Terumo Europe N.V.. It received FDA 510(k) clearance on 2004-05-28 under 510(k) number K041358. The device is classified under product code JKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VENOJECT LUER ADAPTER?

VENOJECT LUER ADAPTER is a medical device that received FDA 510(k) clearance on 2004-05-28. The listed applicant is Terumo Europe N.V.. The 510(k) number is K041358.

When did VENOJECT LUER ADAPTER receive FDA 510(k) clearance?

VENOJECT LUER ADAPTER received FDA 510(k) clearance on 2004-05-28, under 510(k) number K041358.

Who is the listed applicant for VENOJECT LUER ADAPTER?

The FDA 510(k) record lists Terumo Europe N.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VENOJECT LUER ADAPTER?

The FDA product code for VENOJECT LUER ADAPTER is JKA.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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