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FDA 510(k) Application Details - K212817
Device Classification Name
Device, Vascular, For Promoting Embolization
More FDA Info for this Device
510(K) Number
K212817
Device Name
Device, Vascular, For Promoting Embolization
Applicant
Merit Medical System, Inc.
1600 West Merit Parkway
South Jordan, UT 84095 US
Other 510(k) Applications for this Company
Contact
Mark Mullaney
Other 510(k) Applications for this Contact
Regulation Number
870.3300
More FDA Info for this Regulation Number
Classification Product Code
KRD
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/03/2021
Decision Date
12/15/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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