FDA 510(k)

PRIMARY IV SET

K-Number: K964435 · 1997-04-02

Decision Date1997-04-02

Product CodeFMG

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

PRIMARY IV SET is the device name listed in this FDA 510(k) record. The listed applicant is Icu Medical, Inc.. It received FDA 510(k) clearance on 1997-04-02 under 510(k) number K964435. The device is classified under product code FMG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRIMARY IV SET?

PRIMARY IV SET is a medical device that received FDA 510(k) clearance on 1997-04-02. The listed applicant is Icu Medical, Inc.. The 510(k) number is K964435.

When did PRIMARY IV SET receive FDA 510(k) clearance?

PRIMARY IV SET received FDA 510(k) clearance on 1997-04-02, under 510(k) number K964435.

Who is the listed applicant for PRIMARY IV SET?

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

What is the FDA product code for PRIMARY IV SET?

The FDA product code for PRIMARY IV SET is FMG.

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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.