Name: Predicase
Price: 199 USD

K-number	K181051
Device name	IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE Embolization Plug, 10mm
Applicant	Shape Memory Medical
Product code	KRD
Device class	Class II
Decision date	Jun 22, 2018
Decision	Substantially Equivalent
Regulation	870.3300

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 →

IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE Embolization Plug, 10mm

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