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FDA 510(k)

Polyshield Safety IV Catheters

K-Number: K252677 · 2025-11-05

ApplicantPoly Medicure Limited
Decision Date2025-11-05
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Polyshield Safety IV Catheters is a medical device manufactured by Poly Medicure Limited. It received FDA 510(k) clearance on 2025-11-05 under approval number K252677. 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 Polyshield Safety IV Catheters?

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

When was Polyshield Safety IV Catheters approved by the FDA?

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

What company makes Polyshield Safety IV Catheters?

Polyshield Safety IV Catheters is manufactured by Poly Medicure Limited.

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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Other Devices by Poly Medicure Limited

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