FDA 510(k)

Polyfusion IV Administration Sets

Número K: K220312 · 2023-04-12

Data da decisão2023-04-12

Código do produtoFPA

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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Outros registros que listam Poly Medicure Limited como candidato(a)

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 Catheters K232234Nouvo Safety Set K231401Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva K230616Polyguard and Polyshield Safety IV Catheters

Dispositivos Relacionados (Código: FPA)

K254123Ecomed Disposable Administration SetsEcomed Solutions, LLC K261530iiSure Infusion SetDeka Research and Development K252543AMSafe 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 Medical K250325BD Alaris Pump Infusion SetCarefusion (Bd)

Fonte oficial

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