Back to free search
Home / Search / K050627

LIFESTENT TURBO BILIARY STENT SYSTEMS

Edwards Lifesciences, LLC · Class II · Cleared Mar 22, 2005

K-numberK050627
Device nameLIFESTENT TURBO BILIARY STENT SYSTEMS
ApplicantEdwards Lifesciences, LLC
Product codeFGE
Device classClass II
Decision dateMar 22, 2005
DecisionUnknown
Regulation876.5010
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 →

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

14-day free trial. No setup. Cancel anytime.

Start free trial →
Building an AI or ML-enabled device? Predicate search, PCCP tracking, and AI-specific FDA intelligence — built exclusively for AI/ML devices. Try AIFDA Intel →