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FDA 510(k) Application Details - K192267
Device Classification Name
Catheter, Intravascular, Diagnostic
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510(K) Number
K192267
Device Name
Catheter, Intravascular, Diagnostic
Applicant
Abbott Medical
4 Robbins Road
Westford, MA 01886 US
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Contact
Anita Xavier
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
08/21/2019
Decision Date
12/17/2019
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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