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FDA 510(k)

CORE RESISTANT HUBER INFUSION SETS

K-Number: K972712 · 1997-10-01

ApplicantIcu Medical, Inc.
Decision Date1997-10-01
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CORE RESISTANT HUBER INFUSION SETS 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 1997-10-01 under 510(k) number K972712. 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 CORE RESISTANT HUBER INFUSION SETS?

CORE RESISTANT HUBER INFUSION SETS is a medical device that received FDA 510(k) clearance on 1997-10-01. The listed applicant is Icu Medical, Inc.. The 510(k) number is K972712.

When did CORE RESISTANT HUBER INFUSION SETS receive FDA 510(k) clearance?

CORE RESISTANT HUBER INFUSION SETS received FDA 510(k) clearance on 1997-10-01, under 510(k) number K972712.

Who is the listed applicant for CORE RESISTANT HUBER INFUSION SETS?

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 CORE RESISTANT HUBER INFUSION SETS?

The FDA product code for CORE RESISTANT HUBER INFUSION SETS is FPA.

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Other records listing Icu Medical, Inc. as applicant

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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.

K254123Ecomed Disposable Administration SetsEcomed Solutions, LLCK261530iiSure Infusion SetDeka Research and DevelopmentK252543AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)Amsino International, Inc.K251375PuraCath Firefly Needleless Connector IT (9005)Puracath Medical, Inc.K251257nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727]Np MedicalK250325BD Alaris Pump Infusion SetCarefusion (Bd)

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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