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FDA 510(k) Application Details - K200206
Device Classification Name
More FDA Info for this Device
510(K) Number
K200206
Device Name
AXS Vecta 71 Intermediate Catheter, AXS Vecta 74 Intermediate Catheter
Applicant
Stryker Neurovascular
47900 Bayside Parkway
Fremont, CA 94538 US
Other 510(k) Applications for this Company
Contact
Shazia Hakim
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
QJP
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/28/2020
Decision Date
02/27/2020
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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