ClaveQS Bag
K-Number: K251980 · 2026-03-20
ApplicantIcu Medical, Inc.
Decision Date2026-03-20
Product CodeKPE
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
ClaveQS Bag is a medical device manufactured by Icu Medical, Inc.. It received FDA 510(k) clearance on 2026-03-20 under approval number K251980. The device is classified under product code KPE. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ClaveQS Bag?
ClaveQS Bag is a medical device that received FDA 510(k) clearance on 2026-03-20. It is manufactured by Icu Medical, Inc.. The 510(k) number is K251980.
When was ClaveQS Bag approved by the FDA?
ClaveQS Bag received FDA 510(k) clearance on 2026-03-20, under approval number K251980.
What company makes ClaveQS Bag?
ClaveQS Bag is manufactured by Icu Medical, Inc..
What is the FDA product code for ClaveQS Bag?
The FDA product code for ClaveQS Bag is KPE.
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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.