Name: Predicase
Price: 199 USD

K-number	K233448
Device name	Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set
Applicant	Integra Lifesciences Production Corporation
Product code	JXG
Device class	Class II
Decision date	Dec 19, 2023
Decision	Substantially Equivalent
Regulation	882.5550

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Source

View the full FDA submission: accessdata.fda.gov

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Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set

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