FDA 510(k)

Polyshield Safety IV Catheters

Número K: K252677 · 2025-11-05

Data da decisão2025-11-05

Código do produtoFOZ

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Polyshield Safety IV Catheters 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 2025-11-05 under 510(k) number K252677. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Polyshield Safety IV Catheters?

Polyshield Safety IV Catheters is a medical device that received FDA 510(k) clearance on 2025-11-05. The listed applicant is Poly Medicure Limited. The 510(k) number is K252677.

When did Polyshield Safety IV Catheters receive FDA 510(k) clearance?

Polyshield Safety IV Catheters received FDA 510(k) clearance on 2025-11-05, under 510(k) number K252677.

Who is the listed applicant for Polyshield Safety IV Catheters?

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 Polyshield Safety IV Catheters?

The FDA product code for Polyshield Safety IV Catheters is FOZ.

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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)K232234Nouvo Safety Set K231401Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva K230616Polyguard and Polyshield Safety IV Catheters K220312Polyfusion IV Administration Sets

Dispositivos Relacionados (Código: FOZ)

K260432Ruby Intravascular CatheterVenocare, Inc.K260165Unimpregnated Central Venous CatheterSpectrum Vascular K261041ClearSafe Closed SystemMedSource Labs, LLC K260539MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ Safety IV CatheterMedSource Labs, LLC K253235Introcan Safety® Deep Access XL IV CatheterB.Braun Medical, Inc.K252137BD Insyte™ IV CatheterBecton Dickinson Infusion Therapy Systems, Inc.

Fonte oficial

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