Name: Predicase
Price: 199 USD

K-number	K163426
Device name	ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire Extension
Applicant	Asahi Intecc Co., Ltd.
Product code	DQX
Device class	Class II
Decision date	Apr 3, 2017
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 →

ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire Extension

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