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FDA 510(k)

PowerLoc MAX Power Injectable Infusion Set, SafeStep Huber Needle Set

K-Number: K153440 · 2016-08-18

ApplicantC.R. Bard, Inc.
Decision Date2016-08-18
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PowerLoc MAX Power Injectable Infusion Set, SafeStep Huber Needle Set is a medical device manufactured by C.R. Bard, Inc.. It received FDA 510(k) clearance on 2016-08-18 under approval number K153440. The device is classified under product code FPA. 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 2016-08-18. It is manufactured by C.R. Bard, Inc.. The 510(k) number is K153440.

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 2016-08-18, under approval number K153440.

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 C.R. Bard, 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 FPA.

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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.

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