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FDA 510(k)

Clave™ Neutral-Displacement Needlefree Connectors

K-Number: K250616 · 2025-06-05

ApplicantIcu Medical, Inc.
Decision Date2025-06-05
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Clave™ Neutral-Displacement Needlefree Connectors 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 2025-06-05 under 510(k) number K250616. 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 Clave™ Neutral-Displacement Needlefree Connectors?

Clave™ Neutral-Displacement Needlefree Connectors is a medical device that received FDA 510(k) clearance on 2025-06-05. The listed applicant is Icu Medical, Inc.. The 510(k) number is K250616.

When did Clave™ Neutral-Displacement Needlefree Connectors receive FDA 510(k) clearance?

Clave™ Neutral-Displacement Needlefree Connectors received FDA 510(k) clearance on 2025-06-05, under 510(k) number K250616.

Who is the listed applicant for Clave™ Neutral-Displacement Needlefree Connectors?

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 Clave™ Neutral-Displacement Needlefree Connectors?

The FDA product code for Clave™ Neutral-Displacement Needlefree Connectors is FPA.

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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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