Name: Predicase
Price: 199 USD

K-number	K172238
Device name	CAREline Airless Hemodialysis Blood Tubing Sets
Applicant	Fresenius Medical Care Renal Therapies Group, LLC
Product code	KOC
Device class	Class II
Decision date	Dec 14, 2017
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 →

CAREline Airless Hemodialysis Blood Tubing Sets

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