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FDA 510(k)

Polyfusion IV Administration Sets

K-Number: K220312 · 2023-04-12

ApplicantPoly Medicure Limited
Decision Date2023-04-12
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Polyfusion IV Administration Sets is a medical device manufactured by Poly Medicure Limited. It received FDA 510(k) clearance on 2023-04-12 under approval number K220312. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Polyfusion IV Administration Sets?

Polyfusion IV Administration Sets is a medical device that received FDA 510(k) clearance on 2023-04-12. It is manufactured by Poly Medicure Limited. The 510(k) number is K220312.

When was Polyfusion IV Administration Sets approved by the FDA?

Polyfusion IV Administration Sets received FDA 510(k) clearance on 2023-04-12, under approval number K220312.

What company makes Polyfusion IV Administration Sets?

Polyfusion IV Administration Sets is manufactured by Poly Medicure Limited.

What is the FDA product code for Polyfusion IV Administration Sets?

The FDA product code for Polyfusion IV Administration Sets is FPA.

Other Devices by Poly Medicure Limited

K231401Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva K230616Polyguard and Polyshield Safety IV Catheters 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: FPA)

K160007Paclitaxel SetsBaxter Healthcare Corporation K162304Q2 Multiport IV Administration Sets and Extension Sets, Checkmate Multiport IV Administration Sets, Q2 Extension SetsQuest Medical, Inc. K161323Solution Set for Epidural UseBaxter Healthcare Corporation K153731LifeFlow Rapid Infusion Device (LifeFlow Device)410 Medical Innovation, LLC K153440PowerLoc MAX Power Injectable Infusion Set, SafeStep Huber Needle SetC.R. Bard, Inc. K160648MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio®Unomedical A/S

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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