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FDA 510(k)

UNIVERSAL VIAL ACCESS SPIKE

K-Number: K080989 · 2008-05-02

ApplicantIcu Medical, Inc.
Decision Date2008-05-02
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

UNIVERSAL VIAL ACCESS SPIKE 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 2008-05-02 under 510(k) number K080989. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNIVERSAL VIAL ACCESS SPIKE?

UNIVERSAL VIAL ACCESS SPIKE is a medical device that received FDA 510(k) clearance on 2008-05-02. The listed applicant is Icu Medical, Inc.. The 510(k) number is K080989.

When did UNIVERSAL VIAL ACCESS SPIKE receive FDA 510(k) clearance?

UNIVERSAL VIAL ACCESS SPIKE received FDA 510(k) clearance on 2008-05-02, under 510(k) number K080989.

Who is the listed applicant for UNIVERSAL VIAL ACCESS SPIKE?

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 UNIVERSAL VIAL ACCESS SPIKE?

The FDA product code for UNIVERSAL VIAL ACCESS SPIKE is FMF.

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Related Devices (Code: FMF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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