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FDA 510(k) Application Details - K143398
Device Classification Name
Catheter, Intravascular, Diagnostic
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510(K) Number
K143398
Device Name
Catheter, Intravascular, Diagnostic
Applicant
SCIENTIA VASCULAR , LLC
2700 SOUTH 900 WEST
SUITE D
SALT LAKE CITY, UT 84119 US
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Contact
Sharon Rockwell
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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
11/26/2014
Decision Date
06/26/2015
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
Y
Expedited Review
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