Name: Predicase
Price: 199 USD

K-number	K252442
Device name	Kii Structural Balloon Access System
Applicant	Applied Medical Resources Corp.
Product code	GCJ
Device class	Class II
Decision date	Oct 31, 2025
Decision	Substantially Equivalent
Regulation	876.1500

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

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Kii Structural Balloon Access System

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