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FDA 510(k)

ACCU-CHEK ULTRAFLEX INFUSION SET

K-Number: K122686 · 2012-11-16

ApplicantRoche Diabetes Care AG
Decision Date2012-11-16
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ACCU-CHEK ULTRAFLEX INFUSION SET is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diabetes Care AG. It received FDA 510(k) clearance on 2012-11-16 under 510(k) number K122686. 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 ACCU-CHEK ULTRAFLEX INFUSION SET?

ACCU-CHEK ULTRAFLEX INFUSION SET is a medical device that received FDA 510(k) clearance on 2012-11-16. The listed applicant is Roche Diabetes Care AG. The 510(k) number is K122686.

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

ACCU-CHEK ULTRAFLEX INFUSION SET received FDA 510(k) clearance on 2012-11-16, under 510(k) number K122686.

Who is the listed applicant for ACCU-CHEK ULTRAFLEX INFUSION SET?

The FDA 510(k) record lists Roche Diabetes Care AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACCU-CHEK ULTRAFLEX INFUSION SET?

The FDA product code for ACCU-CHEK ULTRAFLEX INFUSION SET is FPA.

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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