Cleared Traditional

Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva

K231401 · Poly Medicure Limited · General Hospital

Sep 2023

Decision

129d

Days

Class 2

Risk

About This 510(k) Submission

K231401 is an FDA 510(k) clearance for the Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva, 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 September 21, 2023, 129 days after receiving the submission on May 15, 2023. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5200.

Submission Details

510(k) Number	K231401 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 15, 2023
Decision Date	September 21, 2023
Days to Decision	129 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