Name: Predicase
Price: 199 USD

K-number	K920846
Device name	CENTRAL VENOUS CATHETER, DRESSING CHANGE KIT, STER
Applicant	Trinity Laboratories, Inc.
Product code	FXX
Device class	Class II
Decision date	Sep 1, 1992
Decision	Substantially Equivalent — Kit Device
Regulation	878.4040

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 →

CENTRAL VENOUS CATHETER, DRESSING CHANGE KIT, STER

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