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FDA 510(k) Application Details - K190833
Device Classification Name
Catheter, Percutaneous
More FDA Info for this Device
510(K) Number
K190833
Device Name
Catheter, Percutaneous
Applicant
Stryker Neurovascular
47900 Bayside Parkway
Fremont, CA 94538 US
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Contact
Shazia Hakim
Other 510(k) Applications for this Contact
Regulation Number
870.1250
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Classification Product Code
DQY
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More FDA Info for this Product Code
Date Received
04/01/2019
Decision Date
12/15/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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