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FDA 510(k) Application Details - K230402
Device Classification Name
Temporary Carotid Catheter For Embolic Capture
More FDA Info for this Device
510(K) Number
K230402
Device Name
Temporary Carotid Catheter For Embolic Capture
Applicant
Silk Road Medical
1213 Innsbruck Drive
Sunnyvale, CA 94089 US
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Contact
Denise Aycox
Other 510(k) Applications for this Contact
Regulation Number
870.1250
More FDA Info for this Regulation Number
Classification Product Code
NTE
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More FDA Info for this Product Code
Date Received
02/15/2023
Decision Date
04/11/2023
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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