Name: Predicase
Price: 199 USD

K-number	K011804
Device name	CAPIOX ARTERIAL FILTER WITH X-COATING, PRODUCT CODE CX*AFO2X
Applicant	Terumo Cardiovascular Systems Corp.
Product code	DTM
Device class	Class II
Decision date	Jul 9, 2001
Decision	Substantially Equivalent
Regulation	870.4260

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 →

CAPIOX ARTERIAL FILTER WITH X-COATING, PRODUCT CODE CX*AFO2X

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