FDA 510(k) Application Details - K200871

Device Classification Name	More FDA Info for this Device
510(K) Number	K200871
Device Name	Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire Mechanical Aspirator
Applicant	Control Medical Technology 2757 South 300 West Suite F (ZIEN) Salt Lake City, UT 84115 US Other 510(k) Applications for this Company
Contact	Shawn Fojtik Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QEZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/01/2020
Decision Date	05/04/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review