K-number	K162704
Device name	Axium Prime Detachable Coil System
Applicant	Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
Product code	HCG
Device class	Class II
Decision date	Jan 3, 2017
Decision	Substantially Equivalent
Regulation	882.5950

AI Summary

AI extraction for this record is queued and will appear within 24 hours. View full FDA record →

Source

View the full FDA submission: accessdata.fda.gov

Researching this as a predicate?

Want a transparent AI-ranking score, AI-discovered related predicates, ongoing safety and warning-letter monitoring, full predicate chain lineage, and a drafted SE rationale — all saved to your own project? That's what an account adds.

Start free trial →

Building an AI or ML-enabled device? Predicate search, PCCP tracking, and AI-specific FDA intelligence — built exclusively for AI/ML devices. Try AIFDA Intel →

Axium Prime Detachable Coil System

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