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FDA 510(k) Application Details - K172394
Device Classification Name
Catheter, Steerable
More FDA Info for this Device
510(K) Number
K172394
Device Name
Catheter, Steerable
Applicant
Abbott Vascular
3200 Lakeside Drive
Santa Clara, CA 95054 US
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Contact
Makena Mc Gowan
Other 510(k) Applications for this Contact
Regulation Number
870.1280
More FDA Info for this Regulation Number
Classification Product Code
DRA
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More FDA Info for this Product Code
Date Received
08/08/2017
Decision Date
09/06/2017
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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