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FDA 510(k)

Polyguard and Polyshield Safety IV Catheters

K-Number: K230616 · 2023-05-05

ApplicantPoly Medicure Limited
Decision Date2023-05-05
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Polyguard and Polyshield Safety IV Catheters is a medical device manufactured by Poly Medicure Limited. It received FDA 510(k) clearance on 2023-05-05 under approval number K230616. 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 Polyguard and Polyshield Safety IV Catheters?

Polyguard and Polyshield Safety IV Catheters is a medical device that received FDA 510(k) clearance on 2023-05-05. It is manufactured by Poly Medicure Limited. The 510(k) number is K230616.

When was Polyguard and Polyshield Safety IV Catheters approved by the FDA?

Polyguard and Polyshield Safety IV Catheters received FDA 510(k) clearance on 2023-05-05, under approval number K230616.

What company makes Polyguard and Polyshield Safety IV Catheters?

Polyguard and Polyshield Safety IV Catheters is manufactured by Poly Medicure Limited.

What is the FDA product code for Polyguard and Polyshield Safety IV Catheters?

The FDA product code for Polyguard and 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 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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