Name: Predicase
Price: 199 USD

K-number	K063293
Device name	EDWARDS AQUALINE STERILE TUBING SET; EDWARDS AQUALINS STERILE TUBING SET; EDWARDS AQUASPIKE AND AQUASAFE
Applicant	Edwards Lifesciences Services GmbH
Product code	FJK
Device class	Class II
Decision date	Mar 23, 2007
Decision	Substantially Equivalent
Regulation	876.5820

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 →

EDWARDS AQUALINE STERILE TUBING SET; EDWARDS AQUALINS STERILE TUBING SET; EDWARDS AQUASPIKE AND AQUASAFE

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