Back to free search
Home / Search / K012209

CAPIOX SP PUMP WITH X-COATING PRODUCT CODE: CXSP45X

Terumo Cardiovascular Systems Corp. · Class II · Cleared Aug 15, 2001

K-numberK012209
Device nameCAPIOX SP PUMP WITH X-COATING PRODUCT CODE: CXSP45X
ApplicantTerumo Cardiovascular Systems Corp.
Product codeKFM
Device classClass II
Decision dateAug 15, 2001
DecisionSubstantially Equivalent
Regulation870.4360
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 →

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

14-day free trial. No setup. Cancel anytime.

Start free trial →
Building an AI or ML-enabled device? Predicate search, PCCP tracking, and AI-specific FDA intelligence — built exclusively for AI/ML devices. Try AIFDA Intel →