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FDA 510(k)

ANTIMICROBIAL CLAVE, MODELS AG CLAVE, AG MICROCLAVE

K-Number: K090189 · 2009-04-10

Decision Date2009-04-10
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ANTIMICROBIAL CLAVE, MODELS AG CLAVE, AG MICROCLAVE 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 2009-04-10 under 510(k) number K090189. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANTIMICROBIAL CLAVE, MODELS AG CLAVE, AG MICROCLAVE?

ANTIMICROBIAL CLAVE, MODELS AG CLAVE, AG MICROCLAVE is a medical device that received FDA 510(k) clearance on 2009-04-10. The listed applicant is Icu Medical, Inc.. The 510(k) number is K090189.

When did ANTIMICROBIAL CLAVE, MODELS AG CLAVE, AG MICROCLAVE receive FDA 510(k) clearance?

ANTIMICROBIAL CLAVE, MODELS AG CLAVE, AG MICROCLAVE received FDA 510(k) clearance on 2009-04-10, under 510(k) number K090189.

Who is the listed applicant for ANTIMICROBIAL CLAVE, MODELS AG CLAVE, AG MICROCLAVE?

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 ANTIMICROBIAL CLAVE, MODELS AG CLAVE, AG MICROCLAVE?

The FDA product code for ANTIMICROBIAL CLAVE, MODELS AG CLAVE, AG MICROCLAVE is FPA.

Related Clinical Trials

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.

Other records listing Icu Medical, Inc. as applicant

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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Related Devices (Code: FPA)

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.

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.

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