Name: Predicase
Price: 199 USD

K-number	K211276
Device name	Reprocessed Dynamic Tip and XT Steerable Diagnostic Electrophysiology Catheters
Applicant	Innovative Health, LLC
Product code	NLH
Device class	Class II
Decision date	Sep 15, 2021
Decision	Substantially Equivalent
Regulation	870.1220

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Source

View the full FDA submission: accessdata.fda.gov

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Reprocessed Dynamic Tip and XT Steerable Diagnostic Electrophysiology Catheters

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