510(k) K241353

PowerLoc Max Power Injectable Infusion Set; SafeStep Huber Needle Set by Bard Access Systems, Inc. — Product Code PTI

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: November 27, 2024
Date Received: May 13, 2024
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Non-Coring (Huber) Needle
Device Class: Class II
Regulation Number: 880.5570
Review Panel: HO
Submission Type

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.

Other clearances by Bard Access Systems, Inc.

K252478 — Vaccess CT Low-Profile Power-Injectable Implantable Port; Vaccess CT Power-Inj (September 5, 2025)
K251253 — PowerPort isp Implantable Port; PowerPort Slim Implantable Port; PowerPort M. (June 18, 2025)
K242328 — PowerPort ClearVUE Slim Implantable Ports and PowerPort ClearVUE Slim Implan (October 31, 2024)
K240146 — BD Prevue II Peripheral Vascular Access System (February 18, 2024)
K223198 — BD Intraosseous Vascular Access System EMS Powered Driver (D001003) (November 10, 2022)
K222232 — Sherlock 3CG® Tip Positioning System (TPS) Stylet/T-Lock Assembly (August 24, 2022)
K210264 — BD PowerPiCC Catheter (July 30, 2021)
K120882 — SITE RITE PREVUE ULTRASOUND SYSTEM AND PINPOINT NEEDLE GUIDE (May 30, 2012)
K100402 — SITE-RITE VISION ULTRASOUND SYSTEM (March 5, 2010)
K071095 — ASPIRA PLEURAL DRAINAGE SYSTEM (May 18, 2007)

Other clearances for product code PTI

K252355 — K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing (November 26, 2025)
K251138 — Promisemed Safety Huber Needles (May 13, 2025)
K243332 — Promisemed Safety Huber Needles (March 14, 2025)
K230715 — Promisemed Safety Huber Needle (June 8, 2023)
K213823 — Intera Refill Kit (March 16, 2022)
K211121 — Intera Non-coring (Huber) Refill Needles, Intera Non-coring (Huber) Special bolu (October 14, 2021)
K200463 — Huber Needle Infusion Set, Safety Huber Needle Infusion Set (April 7, 2021)
K170881 — ISP Safety Huber Needle Infusion Set (December 14, 2017)
K170897 — Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle wit (November 3, 2017)
K171735 — PowerLoc MAX Power-Injectable Infusion Set and SafeStep Huber Needle Set (August 8, 2017)