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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 the device name listed in this FDA 510(k) record. The listed applicant is C.R. Bard, Inc.. It received FDA 510(k) clearance on 2016-08-18 under 510(k) 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. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K153440.

When did PowerLoc MAX Power Injectable Infusion Set, SafeStep Huber Needle Set receive FDA 510(k) clearance?

PowerLoc MAX Power Injectable Infusion Set, SafeStep Huber Needle Set received FDA 510(k) clearance on 2016-08-18, under 510(k) number K153440.

Who is the listed applicant for PowerLoc MAX Power Injectable Infusion Set, SafeStep Huber Needle Set?

The FDA 510(k) record lists C.R. Bard, Inc. as the applicant. This does not by itself establish the device manufacturer.

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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Related Devices (Code: 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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