FDA 510(k)

PowerLoc™ Max Power Injectable Infusion Set; SafeStep™ Huber Needle Set

Numéro K : K241353 · 2024-11-27

Date de décision2024-11-27

Code produitPTI

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

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 Bard Access Systems, Inc.. It received FDA 510(k) clearance on 2024-11-27 under 510(k) number K241353. The device is classified under product code PTI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

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. The listed applicant is Bard Access Systems, Inc.. The 510(k) number is K241353.

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 2024-11-27, under 510(k) number K241353.

Who is the listed applicant for PowerLoc™ Max Power Injectable Infusion Set; SafeStep™ Huber Needle Set?

The FDA 510(k) record lists Bard Access Systems, 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 PTI.

Essais cliniques associés

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Dispositifs connexes (Code : PTI)

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Source officielle

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