Name: Predicase
Price: 199 USD

K-number	K953436
Device name	STRATO/INFUSAID INFUSE-A-CATH SINGLE LUMEN SILICONE CENTRAL VENOUS CATHETER SYSTESM
Applicant	Strato/Infusaid, Inc.
Product code	LJS
Device class	Class II
Decision date	Oct 4, 1995
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 →

STRATO/INFUSAID INFUSE-A-CATH SINGLE LUMEN SILICONE CENTRAL VENOUS CATHETER SYSTESM

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