K-number	K891005
Device name	INTRAVASCULAR ADMINI. SET MODELS 60030 & 60050
Applicant	3M Company
Product code	FPK
Device class	Class II
Decision date	May 11, 1989
Decision	Substantially Equivalent
Regulation	880.5440

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 →

INTRAVASCULAR ADMINI. SET MODELS 60030 & 60050

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