Name: Predicase
Price: 199 USD

K-number	K222538
Device name	NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter
Applicant	Sino Medical Sciences Technology, Inc.
Product code	LOX
Device class	Class II
Decision date	Dec 21, 2022
Decision	Substantially Equivalent
Regulation	870.5100

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Source

View the full FDA submission: accessdata.fda.gov

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NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter

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