ASAP Aspiration Catheter, ASAPLP Aspiration Catheter

Aspiration Thrombectomy Catheter

Merit Medical Systems, Inc.

The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Asap Aspiration Catheter, Asaplp Aspiration Catheter.

Pre-market Notification Details

Device IDK212199
510k NumberK212199
Device Name:ASAP Aspiration Catheter, ASAPLP Aspiration Catheter
ClassificationAspiration Thrombectomy Catheter
Applicant Merit Medical Systems, Inc. 1600 West Merit Parkway South Jordan,  UT  84095
ContactKirk Mcintosh
CorrespondentKirk Mcintosh
Merit Medical Systems, Inc. 1600 West Merit Parkway South Jordan,  UT  84095
Product CodeQEZ  
CFR Regulation Number870.5150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-07-14
Decision Date2021-11-03

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