Name: Predicase
Price: 199 USD

K-number	K181807
Device name	Solitaire 2 Revascularization Device, Solitaire Platinum Revascularization Device (Solitaire Revascularization Device)
Applicant	Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
Product code	POL
Device class	Class II
Decision date	Mar 6, 2019
Decision	Substantially Equivalent
Regulation	882.5600

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 →

Solitaire 2 Revascularization Device, Solitaire Platinum Revascularization Device (Solitaire Revascularization Device)

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