K-number	K091989
Device name	PERFADEX AND PERFADEX WITH THAM
Applicant	Xvivo Perfusion AB
Product code	KDN
Device class	Class II
Decision date	Oct 1, 2010
Decision	Substantially Equivalent
Regulation	876.5880

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 →

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 →

PERFADEX AND PERFADEX WITH THAM

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