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FDA 510(k) Application Details - K193194
Device Classification Name
Wire, Guide, Catheter
More FDA Info for this Device
510(K) Number
K193194
Device Name
Wire, Guide, Catheter
Applicant
Scientia Cardio Access LLC
3487 West 2100 South Suite 100
West Valley City, UT 84119 US
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Contact
Amy McManus
Other 510(k) Applications for this Contact
Regulation Number
870.1330
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Classification Product Code
DQX
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More FDA Info for this Product Code
Date Received
11/19/2019
Decision Date
12/13/2019
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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