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FDA 510(k) Application Details - K203219
Device Classification Name
More FDA Info for this Device
510(K) Number
K203219
Device Name
Trevo XP ProVue Retriever and Trevo NXTÖ ProVue Retriever
Applicant
Stryker Neurovascular
47900 Bayside Parkway
Fremont, CA 94538 US
Other 510(k) Applications for this Company
Contact
Kathy Nguyen
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
POL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/02/2020
Decision Date
12/29/2020
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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