Name: Predicase
Price: 199 USD

K-number	K221528
Device name	Fogarty Dilation Atrioseptostomy Catheter, Miller Balloon Atrioseptostomy Catheter
Applicant	Edwards Lifesciences, LLC
Product code	DXF
Device class	Class II
Decision date	Aug 22, 2022
Decision	Substantially Equivalent
Regulation	870.5175

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 →

Fogarty Dilation Atrioseptostomy Catheter, Miller Balloon Atrioseptostomy Catheter

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