K-number	K213166
Device name	Thrombuster II Aspiration Catheter
Applicant	Kaneka Medical America, LLC
Product code	QEZ
Device class	Class II
Decision date	Oct 26, 2021
Decision	Substantially Equivalent
Regulation	870.5150

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Source

View the full FDA submission: accessdata.fda.gov

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Thrombuster II Aspiration Catheter

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