Cleared Traditional

Polyguard and Polyshield Safety IV Catheters

K230616 · Poly Medicure Limited · General Hospital

May 2023

Decision

60d

Days

Class 2

Risk

About This 510(k) Submission

K230616 is an FDA 510(k) clearance for the Polyguard and 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 May 5, 2023, 60 days after receiving the submission on March 6, 2023. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5200.

Submission Details

510(k) Number	K230616 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 06, 2023
Decision Date	May 05, 2023
Days to Decision	60 days
Submission Type	Traditional
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