Name: Predicase
Price: 199 USD

K-number	K051194
Device name	BD ONECATH PERIPHERALLY INSERTED CENTRAL CATHETER, MODELS 384647, 384667, 384687, 384648, 384668, 384688, 384649, 384669
Applicant	Becton, Dickinson & CO
Product code	LJS
Device class	Class II
Decision date	Jul 25, 2005
Decision	Substantially Equivalent
Regulation	880.5970

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 →

BD ONECATH PERIPHERALLY INSERTED CENTRAL CATHETER, MODELS 384647, 384667, 384687, 384648, 384668, 384688, 384649, 384669

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