Name: Predicase
Price: 199 USD

K-number	K010162
Device name	EQUINOX OCCULSION BALLOON SYSTEM MODEL # 104-4015, 104-4018, 104-4021, 104-4023, 104-4026
Applicant	Micro Therapeutics, Inc.
Product code	MJN
Device class	Class II
Decision date	May 18, 2001
Decision	Substantially Equivalent
Regulation	870.4450

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 →

EQUINOX OCCULSION BALLOON SYSTEM MODEL # 104-4015, 104-4018, 104-4021, 104-4023, 104-4026

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