K-number	K133631
Device name	LEXIPLIANT DILATOR SHEATH SET
Applicant	Spectranetics Corporation
Product code	DRE
Device class	Class II
Decision date	Mar 27, 2014
Decision	Substantially Equivalent
Regulation	870.1310

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 →

Building an AI or ML-enabled device? Predicate search, PCCP tracking, and AI-specific FDA intelligence — built exclusively for AI/ML devices. Try AIFDA Intel →

LEXIPLIANT DILATOR SHEATH SET

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