Name: Predicase
Price: 199 USD

K-number	K254279
Device name	Edwards eSheath+ introducer set
Applicant	Edwards Lifesciences
Product code	DYB
Device class	Class II
Decision date	Apr 17, 2026
Decision	Substantially Equivalent
Regulation	870.1340

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

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 →

Edwards eSheath+ introducer set

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