Name: Predicase
Price: 199 USD

K-number	K142298
Device name	Shiley Neonatal, Pediatric & Pediatric Long Tracheostomy Tubes with TaperGuard Cuff
Applicant	Covidien
Product code	JOH
Device class	Class II
Decision date	Feb 13, 2015
Decision	Substantially Equivalent
Regulation	868.5800

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 →

Shiley Neonatal, Pediatric & Pediatric Long Tracheostomy Tubes with TaperGuard Cuff

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