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FDA 510(k) Application Details - K191608
Device Classification Name
Catheter, Intravascular, Diagnostic
More FDA Info for this Device
510(K) Number
K191608
Device Name
Catheter, Intravascular, Diagnostic
Applicant
Merit Medical Systems, Inc.
1600 West Merit Parkway
South Jordan, UT 84095 US
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Contact
Luke Meidell
Other 510(k) Applications for this Contact
Regulation Number
870.1200
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Classification Product Code
DQO
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More FDA Info for this Product Code
Date Received
06/17/2019
Decision Date
07/16/2019
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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