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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 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.

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. 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.

Other records listing Poly Medicure Limited as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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 CathetersK232234Nouvo Safety SetK230616Polyguard and Polyshield Safety IV CathetersK220312Polyfusion IV Administration Sets

Related Devices (Code: FOZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260165Unimpregnated Central Venous CatheterSpectrum VascularK261041ClearSafe Closed SystemMedSource Labs, LLCK260539MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ Safety IV CatheterMedSource Labs, LLCK253235Introcan Safety® Deep Access XL IV CatheterB.Braun Medical, Inc.K252137BD Insyte™ IV CatheterBecton Dickinson Infusion Therapy Systems, Inc.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)Poly Medicure Limited

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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