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FDA 510(k)

Q2 IV Administration Sets

K-Number: K213588 · 2022-06-02

ApplicantQuest Medical, Inc.
Decision Date2022-06-02
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Q2 IV Administration Sets is the device name listed in this FDA 510(k) record. The listed applicant is Quest Medical, Inc.. It received FDA 510(k) clearance on 2022-06-02 under 510(k) number K213588. 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 Q2 IV Administration Sets?

Q2 IV Administration Sets is a medical device that received FDA 510(k) clearance on 2022-06-02. The listed applicant is Quest Medical, Inc.. The 510(k) number is K213588.

When did Q2 IV Administration Sets receive FDA 510(k) clearance?

Q2 IV Administration Sets received FDA 510(k) clearance on 2022-06-02, under 510(k) number K213588.

Who is the listed applicant for Q2 IV Administration Sets?

The FDA 510(k) record lists Quest Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Q2 IV Administration Sets?

The FDA product code for Q2 IV Administration Sets 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.

K261530iiSure 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)K251814EZ™ IV Administration SetEpic Medical Pte. , Ltd.

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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