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FDA 510(k) Application Details - K191768
Device Classification Name
Catheter, Thrombus Retriever
More FDA Info for this Device
510(K) Number
K191768
Device Name
Catheter, Thrombus Retriever
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
NRY
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More FDA Info for this Product Code
Date Received
07/01/2019
Decision Date
07/30/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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