K-number	K970638
Device name	CTS MIDCAB FIXEDN DIAMETER CORONARY SHUNT
Applicant	Cardiothoracic Systems, Inc.
Product code	DXC
Device class	Class II
Decision date	Oct 30, 1997
Decision	Substantially Equivalent
Regulation	870.4450

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 →

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 →

CTS MIDCAB FIXEDN DIAMETER CORONARY SHUNT

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