Name: Predicase
Price: 199 USD

K-number	K200871
Device name	Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire Mechanical Aspirator
Applicant	Control Medical Technology
Product code	QEZ
Device class	Class II
Decision date	May 4, 2020
Decision	Substantially Equivalent
Regulation	870.5150

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Source

View the full FDA submission: accessdata.fda.gov

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Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire Mechanical Aspirator

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