Name: Predicase
Price: 199 USD

K-number	K120872
Device name	ASANTE CONSET AND ASANTE COMFORT SUBCUTANEOUS INFUSION SETS FOR USE WITH ASANTE PEARL INFUSION PUMPS
Applicant	Unomedical A/S Infusion Devices
Product code	FPA
Device class	Class II
Decision date	Apr 20, 2012
Decision	Substantially Equivalent
Regulation	880.5440

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 →

ASANTE CONSET AND ASANTE COMFORT SUBCUTANEOUS INFUSION SETS FOR USE WITH ASANTE PEARL INFUSION PUMPS

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