Name: Predicase
Price: 199 USD

K-number	K093730
Device name	PORT ACCESS SYSTEMS ENDODIRECT ARTERIAL CANNULA MODEL ED24 (OLD CODE WAS-DFK24)
Applicant	Edwards Lifesciences, LLC
Product code	DWF
Device class	Class II
Decision date	Jan 14, 2010
Decision	Substantially Equivalent
Regulation	870.4210

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 →

PORT ACCESS SYSTEMS ENDODIRECT ARTERIAL CANNULA MODEL ED24 (OLD CODE WAS-DFK24)

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