Name: Predicase
Price: 199 USD

K-number	K122854
Device name	ARROW GLIDETHRU PEEL-AWAY SHEATH/DILATOR INTRODUCER
Applicant	Arrow International (Subsidiary of Teleflex Inc.)
Product code	DYB
Device class	Class II
Decision date	Jan 4, 2013
Decision	Substantially Equivalent
Regulation	870.1340

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 →

ARROW GLIDETHRU PEEL-AWAY SHEATH/DILATOR INTRODUCER

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