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FDA 510(k)

PowerLoc MAX Power-Injectable Infusion Set and SafeStep Huber Needle Set

K-Number: K171735 · 2017-08-08

ApplicantC.R. Bard, Inc.
Decision Date2017-08-08
Product CodePTI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PowerLoc MAX Power-Injectable Infusion Set and SafeStep Huber Needle Set is a medical device manufactured by C.R. Bard, Inc.. It received FDA 510(k) clearance on 2017-08-08 under approval number K171735. 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 and SafeStep Huber Needle Set?

PowerLoc MAX Power-Injectable Infusion Set and SafeStep Huber Needle Set is a medical device that received FDA 510(k) clearance on 2017-08-08. It is manufactured by C.R. Bard, Inc.. The 510(k) number is K171735.

When was PowerLoc MAX Power-Injectable Infusion Set and SafeStep Huber Needle Set approved by the FDA?

PowerLoc MAX Power-Injectable Infusion Set and SafeStep Huber Needle Set received FDA 510(k) clearance on 2017-08-08, under approval number K171735.

What company makes PowerLoc MAX Power-Injectable Infusion Set and SafeStep Huber Needle Set?

PowerLoc MAX Power-Injectable Infusion Set and SafeStep Huber Needle Set is manufactured by C.R. Bard, Inc..

What is the FDA product code for PowerLoc MAX Power-Injectable Infusion Set and SafeStep Huber Needle Set?

The FDA product code for PowerLoc MAX Power-Injectable Infusion Set and SafeStep Huber Needle Set is PTI.

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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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