Name: Predicase
Price: 199 USD

K-number	K162448
Device name	White Sizing Catheter, Aurous Centimeter Sizing Catheter, Cava Vessel Sizing Catheter
Applicant	Cook Incorporated
Product code	DQO
Device class	Class II
Decision date	May 26, 2017
Decision	Substantially Equivalent
Regulation	870.1200

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 →

White Sizing Catheter, Aurous Centimeter Sizing Catheter, Cava Vessel Sizing Catheter

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