Name: Predicase
Price: 199 USD

K-number	K051337
Device name	EAGLE EYE GOLD IVUS IMAGING CATHETER, MODEL 85900/859XX; VOLCANO VH-IVUS SYSTEM, MODEL 8049XX-001
Applicant	Volcano Corporation
Product code	OBJ
Device class	Class II
Decision date	Aug 18, 2005
Decision	Substantially Equivalent
Regulation	870.1200

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 →

EAGLE EYE GOLD IVUS IMAGING CATHETER, MODEL 85900/859XX; VOLCANO VH-IVUS SYSTEM, MODEL 8049XX-001

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