Name: Predicase
Price: 199 USD

K-number	K052480
Device name	HANSEN MEDICAL CATHETER CONTROL SYSTEM (CCS) AND ACCESSORIES, HANSEN MEDICAL STEERABLE GUIDE CATHETER (SGC) AND SHEATH
Applicant	Hansen Medical, Inc.
Product code	DXX
Device class	Class II
Decision date	May 2, 2007
Decision	Unknown
Regulation	870.1290

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 →

HANSEN MEDICAL CATHETER CONTROL SYSTEM (CCS) AND ACCESSORIES, HANSEN MEDICAL STEERABLE GUIDE CATHETER (SGC) AND SHEATH

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