Name: Predicase
Price: 199 USD

K-number	K171275
Device name	Micropuncture Introducer Set, Micropuncture Introducer Set with Push-Plus Design, Micropuncture Introducer Set with Silhouette Transitionless Design, Micropuncture Introducer Set with Silhouette Transitionless Design and Push-Plus Design
Applicant	Cook Incorporated
Product code	DYB
Device class	Class II
Decision date	Dec 20, 2017
Decision	Unknown
Regulation	870.1340

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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Micropuncture Introducer Set, Micropuncture Introducer Set with Push-Plus Design, Micropuncture Introducer Set with Silhouette Transitionless Design, Micropuncture Introducer Set with Silhouette Transitionless Design and Push-Plus Design

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