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FDA 510(k)

Safety Subcutaneous Infusion Set

K-Number: K201626 · 2021-03-24

ApplicantEpic Medical Pte. , Ltd.
Decision Date2021-03-24
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Safety Subcutaneous Infusion Set is the device name listed in this FDA 510(k) record. The listed applicant is Epic Medical Pte. , Ltd.. It received FDA 510(k) clearance on 2021-03-24 under 510(k) number K201626. 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 Safety Subcutaneous Infusion Set?

Safety Subcutaneous Infusion Set is a medical device that received FDA 510(k) clearance on 2021-03-24. The listed applicant is Epic Medical Pte. , Ltd.. The 510(k) number is K201626.

When did Safety Subcutaneous Infusion Set receive FDA 510(k) clearance?

Safety Subcutaneous Infusion Set received FDA 510(k) clearance on 2021-03-24, under 510(k) number K201626.

Who is the listed applicant for Safety Subcutaneous Infusion Set?

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

What is the FDA product code for Safety Subcutaneous Infusion Set?

The FDA product code for Safety Subcutaneous Infusion Set is FPA.

Other records listing Epic Medical Pte. , Ltd. 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.

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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