Name: Predicase
Price: 199 USD

K-number	K221986
Device name	XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP Catheter
Applicant	Transit Scientific, LLC
Product code	PNO
Device class	Class II
Decision date	Oct 18, 2022
Decision	Substantially Equivalent
Regulation	870.1250

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 →

XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP Catheter

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