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FDA 510(k)

Polyfusion IV Administration Sets

K-Number: K220312 · 2023-04-12

ApplicantPoly Medicure Limited
Decision Date2023-04-12
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Polyfusion IV Administration Sets is the device name listed in this FDA 510(k) record. The listed applicant is Poly Medicure Limited. It received FDA 510(k) clearance on 2023-04-12 under 510(k) number K220312. 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 Polyfusion IV Administration Sets?

Polyfusion IV Administration Sets is a medical device that received FDA 510(k) clearance on 2023-04-12. The listed applicant is Poly Medicure Limited. The 510(k) number is K220312.

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

Polyfusion IV Administration Sets received FDA 510(k) clearance on 2023-04-12, under 510(k) number K220312.

Who is the listed applicant for Polyfusion IV Administration Sets?

The FDA 510(k) record lists Poly Medicure Limited as the applicant. This does not by itself establish the device manufacturer.

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

The FDA product code for Polyfusion IV Administration Sets is FPA.

Other records listing Poly Medicure Limited 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.

K252513Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm; 20G x 45mm; 22G x 64mm; 22G x 45mm; 24G x 32mm; 24G x 14mm, 26G x 14mm); Polywin Safety Adva (20G x 45mm; 22G x 64mm; 22G x 45mm ; 24G x 32 mm; 24G x 14mm; 14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm, 26G x 14mm)K252677Polyshield Safety IV CathetersK232234Nouvo Safety SetK231401Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety AdvaK230616Polyguard and Polyshield Safety IV Catheters

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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