Cleared Traditional

Polyfusion IV Administration Sets

K220312 · Poly Medicure Limited · General Hospital
Apr 2023
Decision
434d
Days
Class 2
Risk

About This 510(k) Submission

K220312 is an FDA 510(k) clearance for the Polyfusion IV Administration Sets, a Set, Administration, Intravascular (Class II — Special Controls, product code FPA), submitted by Poly Medicure Limited (Jaipur, IN). The FDA issued a Cleared decision on April 12, 2023, 434 days after receiving the submission on February 2, 2022. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K220312 FDA.gov
FDA Decision Cleared SESE
Date Received February 02, 2022
Decision Date April 12, 2023
Days to Decision 434 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FPA — Set, Administration, Intravascular
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5440

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