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FDA 510(k)

TEGO NEEDLE FREE ACCESS ACCESS DEVICE

K-Number: K040710 · 2004-08-11

ApplicantIcu Medical, Inc.
Decision Date2004-08-11
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

TEGO NEEDLE FREE ACCESS ACCESS DEVICE 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 2004-08-11 under 510(k) number K040710. 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 TEGO NEEDLE FREE ACCESS ACCESS DEVICE?

TEGO NEEDLE FREE ACCESS ACCESS DEVICE is a medical device that received FDA 510(k) clearance on 2004-08-11. The listed applicant is Icu Medical, Inc.. The 510(k) number is K040710.

When did TEGO NEEDLE FREE ACCESS ACCESS DEVICE receive FDA 510(k) clearance?

TEGO NEEDLE FREE ACCESS ACCESS DEVICE received FDA 510(k) clearance on 2004-08-11, under 510(k) number K040710.

Who is the listed applicant for TEGO NEEDLE FREE ACCESS ACCESS DEVICE?

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 TEGO NEEDLE FREE ACCESS ACCESS DEVICE?

The FDA product code for TEGO NEEDLE FREE ACCESS ACCESS DEVICE 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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