Name: Predicase
Price: 199 USD

K-number	K103250
Device name	CPS DIRECT SL II SLITTABLE OUTER CATHETER
Applicant	St. Jude Medical, Cardiac Rhythm Management Divisi
Product code	DQY
Device class	Class II
Decision date	Jan 19, 2011
Decision	Substantially Equivalent
Regulation	870.1250

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 →

CPS DIRECT SL II SLITTABLE OUTER CATHETER

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