FDA 510(k)

PowerLoc Max Power Injectable Infusion Set; SafeStep Huber Needle Set

K-Number: K241353 · 2024-11-27

Decision Date2024-11-27

Product CodePTI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

PowerLoc Max Power Injectable Infusion Set; SafeStep Huber Needle Set is a medical device manufactured by Bard Access Systems, Inc.. It received FDA 510(k) clearance on 2024-11-27 under approval number K241353. The device is classified under product code PTI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PowerLoc Max Power Injectable Infusion Set; SafeStep Huber Needle Set?

PowerLoc Max Power Injectable Infusion Set; SafeStep Huber Needle Set is a medical device that received FDA 510(k) clearance on 2024-11-27. It is manufactured by Bard Access Systems, Inc.. The 510(k) number is K241353.

When was PowerLoc Max Power Injectable Infusion Set; SafeStep Huber Needle Set approved by the FDA?

PowerLoc Max Power Injectable Infusion Set; SafeStep Huber Needle Set received FDA 510(k) clearance on 2024-11-27, under approval number K241353.

What company makes PowerLoc Max Power Injectable Infusion Set; SafeStep Huber Needle Set?

PowerLoc Max Power Injectable Infusion Set; SafeStep Huber Needle Set is manufactured by Bard Access Systems, Inc..

What is the FDA product code for PowerLoc Max Power Injectable Infusion Set; SafeStep Huber Needle Set?

The FDA product code for PowerLoc Max Power Injectable Infusion Set; SafeStep Huber Needle Set is PTI.

Related Clinical Trials

NCT07542132 The Effects of Hyaluronic Acid on Skin Health NOT_YET_RECRUITING NCT02633124 Preventing Catheter-related Bacteremia When Administering Injectable Medications in Premature Infants. TERMINATED

Other Devices by Bard Access Systems, Inc.

K210264BD PowerPiCC Catheter K222232Sherlock 3CG® Tip Positioning System (TPS) Stylet/T-Lock Assembly K242328PowerPort ClearVUE Slim Implantable Ports and PowerPort ClearVUE Slim Implantable Ports K240146BD Prevue II Peripheral Vascular Access System K252478Vaccess CT Low-Profile Power-Injectable Implantable Port; Vaccess CT Power-Injectable Implantable Port; PowerPort duo M.R.I. Implantable Port K251253PowerPort isp Implantable Port; PowerPort Slim Implantable Port; PowerPort M.R.I. Implantable Port; PowerPort M.R.I. isp Implantable Port

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Related Devices (Code: PTI)

K170881ISP Safety Huber Needle Infusion SetInfusion Safety Products, Inc. K170897Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle with Caresite Luer Access Device and Y siteB.Braun Medical, Inc. K171735PowerLoc MAX Power-Injectable Infusion Set and SafeStep Huber Needle SetC.R. Bard, Inc. K17133320G x 5/8 Pro-Lock CT Safety Infusion SetMedcomp (Dba Medical Components, Inc.) K162271Pro-Lock CT Safety Infusion SetMedcomp (Medical Components, Inc.) K211121Intera Non-coring (Huber) Refill Needles, Intera Non-coring (Huber) Special bolus Needles and OR Prep KitIntera Oncology, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.