Name: Predicase
Price: 199 USD

K-number	K090512
Device name	POWERPORT DUO M.R.I. IMPLANTED PORT WITH 9.5 FR. DUAL LUMEN CHRONOFLEX POLYURETHANE CATHETER
Applicant	C.R. Bard, Inc.
Product code	LJT
Device class	Class II
Decision date	Mar 27, 2009
Decision	Substantially Equivalent
Regulation	880.5965

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 →

POWERPORT DUO M.R.I. IMPLANTED PORT WITH 9.5 FR. DUAL LUMEN CHRONOFLEX POLYURETHANE CATHETER

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