Cleared Traditional

Huber Needle Infusion Set, Safety Huber Needle Infusion Set

K200463 · Jiangsu Caina Medical Co.,Ltd · General Hospital

Apr 2021

Decision

407d

Days

Class 2

Risk

About This 510(k) Submission

K200463 is an FDA 510(k) clearance for the Huber Needle Infusion Set, Safety Huber Needle Infusion Set, a Non-coring (huber) Needle (Class II — Special Controls, product code PTI), submitted by Jiangsu Caina Medical Co.,Ltd (Jiangyin, CN). The FDA issued a Cleared decision on April 7, 2021, 407 days after receiving the submission on February 25, 2020. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number	K200463 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 25, 2020
Decision Date	April 07, 2021
Days to Decision	407 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

Product Code	PTI — Non-coring (huber) Needle
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 880.5570
Definition	The Non-coring Needle (huber) Is Utilized To Gain Access Into A Subcutaneous Implanted Intravascular Infusion Port But Can Also Be Used To Access Other Non-vascular Implanted Devices With Similar Septums.