Name: Predicase
Price: 199 USD

K-number	K212167
Device name	R350 guidewire, Spectre guidewire, Raider guidewire, Bandit guidewire, Warrior guidewire
Applicant	Vascular Solutions, LLC
Product code	DQX
Device class	Class II
Decision date	Feb 9, 2022
Decision	Substantially Equivalent
Regulation	870.1330

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 →

R350 guidewire, Spectre guidewire, Raider guidewire, Bandit guidewire, Warrior guidewire

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