Cleared Traditional

Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010)

K231363 · Hantech Medical Device Co., Ltd. · General Hospital

Sep 2023

Decision

139d

Days

Class 2

Risk

About This 510(k) Submission

K231363 is an FDA 510(k) clearance for the Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010), a Saline, Vascular Access Flush (Class II — Special Controls, product code NGT), submitted by Hantech Medical Device Co., Ltd. (Ningbo, CN). The FDA issued a Cleared decision on September 27, 2023, 139 days after receiving the submission on May 11, 2023. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5200.

Submission Details

510(k) Number	K231363 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 11, 2023
Decision Date	September 27, 2023
Days to Decision	139 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

Product Code	NGT — Saline, Vascular Access Flush
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 880.5200
Definition	Enhance The Performance Of Intravascular Catheters, To Maintain Patency Of The Vascular Catheter When It Is Not In Use.