K-number	K232945
Device name	Trio-CT® Triple Lumen Catheter w/ Curved Extensions
Applicant	Medical Components, Inc. (dba MedComp)
Product code	NIE
Device class	Class II
Decision date	Nov 16, 2023
Decision	Unknown
Regulation	876.5540

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 →

Trio-CT­® Triple Lumen Catheter w/ Curved Extensions

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

Trio-CT® Triple Lumen Catheter w/ Curved Extensions