Name: Predicase
Price: 199 USD

K-number	K233420
Device name	Axium Detachable Coil; Axium Prime Detachable Coil
Applicant	Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular
Product code	HCG
Device class	Class II
Decision date	Nov 7, 2023
Decision	Substantially Equivalent
Regulation	882.5950

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Source

View the full FDA submission: accessdata.fda.gov

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Axium Detachable Coil; Axium Prime Detachable Coil

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