Name: Predicase
Price: 199 USD

K-number	K241353
Device name	PowerLoc Max Power Injectable Infusion Set; SafeStep Huber Needle Set
Applicant	Bard Access Systems, Inc.
Product code	PTI
Device class	Class II
Decision date	Nov 27, 2024
Decision	Substantially Equivalent
Regulation	880.5570

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Source

View the full FDA submission: accessdata.fda.gov

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

Everything you need for a 510(k) submission. Nothing you don't.

PowerLoc Max Power Injectable Infusion Set; SafeStep Huber Needle Set