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FDA 510(k) Application Details - K173750
Device Classification Name
Introducer, Catheter
More FDA Info for this Device
510(K) Number
K173750
Device Name
Introducer, Catheter
Applicant
Merit Medical Systems, Inc.
1600 West Merit Parkway
South Jordan, UT 84095 US
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Contact
David Thomas
Other 510(k) Applications for this Contact
Regulation Number
870.1340
More FDA Info for this Regulation Number
Classification Product Code
DYB
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More FDA Info for this Product Code
Date Received
12/08/2017
Decision Date
02/15/2018
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
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