Name: Predicase
Price: 199 USD

K-number	K962433
Device name	MEADOX EXXCEL EPTFE VASCULAR GRAFT
Applicant	Meadox Medicals, Div. Boston Scientific Corp.
Product code	DSY
Device class	Class II
Decision date	Mar 17, 1997
Decision	Substantially Equivalent - Subject to Tracking Reg.
Regulation	870.3450

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 →

MEADOX EXXCEL EPTFE VASCULAR GRAFT

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