FDA 510(k)

Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva

N.º K: K231401 · 2023-09-21

Fecha de decisión2023-09-21

Código de productoFOZ

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva 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 2023-09-21 under 510(k) number K231401. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva?

Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva is a medical device that received FDA 510(k) clearance on 2023-09-21. The listed applicant is Poly Medicure Limited. The 510(k) number is K231401.

When did Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva receive FDA 510(k) clearance?

Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva received FDA 510(k) clearance on 2023-09-21, under 510(k) number K231401.

Who is the listed applicant for Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva?

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 Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva?

The FDA product code for Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva is FOZ.

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Otros registros que enlistan a Poly Medicure Limited como solicitante

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 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.

Fuente oficial

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