Name: Predicase
Price: 199 USD

K-number	K200955
Device name	Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid Patch
Applicant	Vascutek, Ltd.
Product code	DXZ
Device class	Class II
Decision date	Jul 8, 2020
Decision	Substantially Equivalent
Regulation	870.3470

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 →

Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid Patch

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