510(k) K171735

PowerLoc MAX Power-Injectable Infusion Set and SafeStep Huber Needle Set by C.R. Bard, Inc. — Product Code PTI

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: August 8, 2017
Date Received: June 12, 2017
Clearance Type: Special
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 C.R. Bard, Inc.

K251864 — Rubber Utility Catheter (February 23, 2026)
K251186 — Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer) (May 15, 2025)
K241334 — Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Elec (January 31, 2025)
K230356 — Aspirex Thrombectomy System (March 31, 2023)
K223177 — Highlander 014 PTA Balloon Dilatation Catheter (January 20, 2023)
K222793 — WavelinQ Generator (October 17, 2022)
K220270 — Aspirex Thrombectomy System (June 21, 2022)
K213203 — Provena(TM) Midline Catheter (May 13, 2022)
K212588 — Conquest 40 PTA Dilatation Catheter, Atlas Gold PTA Dilatation Catheter, Vida PT (May 4, 2022)
K212708 — Halo One Thin-Walled Guiding Sheath (September 23, 2021)

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)
K241353 — PowerLoc Max Power Injectable Infusion Set; SafeStep Huber Needle Set (November 27, 2024)
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)