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

Catheter, Embolectomy

Control Medical Technology

The following data is part of a premarket notification filed by Control Medical Technology with the FDA for Aspire Max 7 - 11f Mechanical Thrombectomy System And Aspire Mechanical Aspirator.

Pre-market Notification Details

Device IDK200871
510k NumberK200871
Device Name:Aspire MAX 7 - 11F Mechanical Thrombectomy System And Aspire Mechanical Aspirator
ClassificationCatheter, Embolectomy
Applicant Control Medical Technology 2757 South 300 West Suite F (ZIEN) Salt Lake City,  UT  84115
ContactShawn Fojtik
CorrespondentShawn Fojtik
Control Medical Technology 2757 South 300 West Suite F (ZIEN) Salt Lake City,  UT  84115
Product CodeDXE  
CFR Regulation Number870.5150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-01
Decision Date2020-05-04

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