Cleared Special

Polyshield Safety IV Catheters

K252677 · Poly Medicure Limited · General Hospital
Nov 2025
Decision
72d
Days
Class 2
Risk

About This 510(k) Submission

K252677 is an FDA 510(k) clearance for the Polyshield Safety IV Catheters, a Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (Class II — Special Controls, product code FOZ), submitted by Poly Medicure Limited (Faridabad, IN). The FDA issued a Cleared decision on November 5, 2025, 72 days after receiving the submission on August 25, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5200.

Submission Details

510(k) Number K252677 FDA.gov
FDA Decision Cleared SESE
Date Received August 25, 2025
Decision Date November 05, 2025
Days to Decision 72 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FOZ — Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5200

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