FDA.reportPublic FDA data

510(k) K241353

Device
PowerLoc? Max Power Injectable Infusion Set; SafeStep? Huber Needle Set
Applicant
Bard Access Systems, Inc.
510(k) number
K241353
Product code
PTI
Decision
Substantially Equivalent (SESE)
Decision date
2024-11-27
Date received
2024-05-13
Regulation
880.5570
Classification name
Non-Coring (Huber) Needle
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Catherine Langford
Address
605 N. 5600 W. Salt Lake Ciy, UT US 84116 84116

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PTI#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K252355K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure TubingSb-Kawasumi Laboratories, Inc.2025-11-26
K251138Promisemed Safety Huber NeedlesPromisemed Hangzhou Meditech Co., Ltd.2025-05-13
K243332Promisemed Safety Huber NeedlesPromisemed Hangzhou Meditech Co., Ltd.2025-03-14
K230715Promisemed Safety Huber NeedlePromisemed Hangzhou Meditech Co., Ltd.2023-06-08
K213823Intera Refill KitIntera Oncology, Inc.2022-03-16
K211121Intera Non-coring (Huber) Refill Needles, Intera Non-coring (Huber) Special bolus Needles and OR Prep KitIntera Oncology, Inc.2021-10-14
K200463Huber Needle Infusion Set, Safety Huber Needle Infusion SetJiangsu Caina Medical Co.,Ltd2021-04-07
K170881ISP Safety Huber Needle Infusion SetInfusion Safety Products, Inc.2017-12-14
K170897Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle with Caresite Luer Access Device and Y siteB.Braun Medical, Inc.2017-11-03
K171735PowerLoc MAX Power-Injectable Infusion Set and SafeStep Huber Needle SetC.R. Bard, Inc.2017-08-08
K17133320G x 5/8 Pro-Lock CT Safety Infusion SetMedcomp (Dba Medical Components, Inc.)2017-07-18
K162271Pro-Lock CT Safety Infusion SetMedcomp (Medical Components, Inc.)2017-04-26