FDA 510(k)

Clave Neutral-Displacement Needlefree Connectors

K-Number: K250616 · 2025-06-05

Decision Date2025-06-05

Product CodeFPA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Clave Neutral-Displacement Needlefree Connectors is a medical device manufactured by Icu Medical, Inc.. It received FDA 510(k) clearance on 2025-06-05 under approval 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. It is manufactured by Icu Medical, Inc.. The 510(k) number is K250616.

When was Clave Neutral-Displacement Needlefree Connectors approved by the FDA?

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

What company makes Clave Neutral-Displacement Needlefree Connectors?

Clave Neutral-Displacement Needlefree Connectors is manufactured by Icu Medical, Inc..

What is the FDA product code for Clave Neutral-Displacement Needlefree Connectors?

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

Other Devices by Icu Medical, Inc.

K152006Cogent Hemodynamic Monitoring System K151969Hospira Extension Sets K173477ChemoCLAVE Cytotoxic Medication Preparation and Delivery System K170110Diana Medication Transfer Set K223607Plum Duo Infusion System K223606LifeShield Infusion Safety Software Suite

View all 14 devices →

Related Devices (Code: FPA)

K160007Paclitaxel SetsBaxter Healthcare Corporation K162304Q2 Multiport IV Administration Sets and Extension Sets, Checkmate Multiport IV Administration Sets, Q2 Extension SetsQuest Medical, Inc. K161323Solution Set for Epidural UseBaxter Healthcare Corporation K153731LifeFlow Rapid Infusion Device (LifeFlow Device)410 Medical Innovation, LLC K153440PowerLoc MAX Power Injectable Infusion Set, SafeStep Huber Needle SetC.R. Bard, Inc. K160648MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio®Unomedical A/S

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.