Cleared Traditional

I.V. Catheter

K142797 · Jiangxi Sanxin Medtec Co., Ltd. · General Hospital

Jun 2015

Decision

262d

Days

Class 2

Risk

About This 510(k) Submission

K142797 is an FDA 510(k) clearance for the I.V. Catheter, a Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (Class II — Special Controls, product code FOZ), submitted by Jiangxi Sanxin Medtec Co., Ltd. (Nanchang, CN). The FDA issued a Cleared decision on June 18, 2015, 262 days after receiving the submission on September 29, 2014. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5200.

Submission Details

510(k) Number	K142797 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 29, 2014
Decision Date	June 18, 2015
Days to Decision	262 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