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FDA 510(k)

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

K-Number: K231401 · 2023-09-21

ApplicantPoly Medicure Limited
Decision Date2023-09-21
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva is a medical device manufactured by Poly Medicure Limited. It received FDA 510(k) clearance on 2023-09-21 under approval number K231401. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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. It is manufactured by Poly Medicure Limited. The 510(k) number is K231401.

When was Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva approved by the FDA?

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

What company makes Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva?

Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva is manufactured by Poly Medicure Limited.

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.

Other Devices by Poly Medicure Limited

K230616Polyguard and Polyshield Safety IV Catheters K220312Polyfusion IV Administration Sets K232234Nouvo Safety Set K252677Polyshield Safety IV Catheters 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)

Related Devices (Code: FOZ)

K162894AccuCath Intravascular CatheterC.R. Bard, Inc. K161779MedSource TrueSafe Safety IV Catheter, MedSource TrueSafe Comfort Safety IV CatheterMedsource International, LLC K162377PowerGlide Pro Midline CatheterC.R. Bard, Inc. K161866BioFlo Midline CatheterNavilyst Medical, Inc. K161777BD Nexiva and BD Nexiva Diffusics Closed IV Catheter SystemsBecton Dickinson Infusion Therapy Systems, Inc. K160592SUPERCATH 6Togo Medikit Co., 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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