Cleared Traditional

PowerLoc? Max Power Injectable Infusion Set; SafeStep? Huber Needle Set

K241353 · Bard Access Systems, Inc. · General Hospital

Nov 2024

Decision

198d

Days

Class 2

Risk

About This 510(k) Submission

K241353 is an FDA 510(k) clearance for the PowerLoc? Max Power Injectable Infusion Set; SafeStep? Huber Needle Set, a Non-coring (huber) Needle (Class II — Special Controls, product code PTI), submitted by Bard Access Systems, Inc. (Salt Lake Ciy,, US). The FDA issued a Cleared decision on November 27, 2024, 198 days after receiving the submission on May 13, 2024. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number	K241353 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 13, 2024
Decision Date	November 27, 2024
Days to Decision	198 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.