Name: Predicase
Price: 199 USD

K-number	K202218
Device name	ZelanteDVT THrombectomy System, ZelanteDVT ClotHunter Helical Rotation Device
Applicant	Boston Scientific Corporation
Product code	QEW
Device class	Class II
Decision date	Oct 2, 2020
Decision	Substantially Equivalent
Regulation	870.5150

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 →

ZelanteDVT THrombectomy System, ZelanteDVT ClotHunter Helical Rotation Device

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