Name: Predicase
Price: 199 USD

K-number	K231248
Device name	Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring Platform
Applicant	Edwards Lifesciencess, LLC
Product code	DYG
Device class	Class II
Decision date	Sep 21, 2023
Decision	Substantially Equivalent
Regulation	870.1240

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 →

Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring Platform

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