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FDA 510(k)

ULTRAFLEX INFUSION SET

K-Number: K033892 · 2004-03-09

ApplicantDisetronic Medical Systems AG
Decision Date2004-03-09
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ULTRAFLEX INFUSION SET is the device name listed in this FDA 510(k) record. The listed applicant is Disetronic Medical Systems AG. It received FDA 510(k) clearance on 2004-03-09 under 510(k) number K033892. 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 ULTRAFLEX INFUSION SET?

ULTRAFLEX INFUSION SET is a medical device that received FDA 510(k) clearance on 2004-03-09. The listed applicant is Disetronic Medical Systems AG. The 510(k) number is K033892.

When did ULTRAFLEX INFUSION SET receive FDA 510(k) clearance?

ULTRAFLEX INFUSION SET received FDA 510(k) clearance on 2004-03-09, under 510(k) number K033892.

Who is the listed applicant for ULTRAFLEX INFUSION SET?

The FDA 510(k) record lists Disetronic Medical Systems AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ULTRAFLEX INFUSION SET?

The FDA product code for ULTRAFLEX INFUSION SET is FPA.

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Other records listing Disetronic Medical Systems AG as applicant

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.

K100704ACCU-CHEK FLEXLINK PLUS INFUSION SET, ACCU-CHECK LINKASSIST PLUS INSERTION DEVICEK070189ACCU-CHEK ULTRAFLEX INFUSION SETK063146ACCU-CHEK LINKASSISTK060876ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWARE (STANDARD), MODEL 04625137001; ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWAK042887ACCU-CHEK SPIRITK043000MODIFICATION TO D-TRONPLUS

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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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