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FDA 510(k) Application Details - K220934
Device Classification Name
Guide, Wire, Catheter, Neurovasculature
More FDA Info for this Device
510(K) Number
K220934
Device Name
Guide, Wire, Catheter, Neurovasculature
Applicant
Terumo Medical Products (Hangzhou) Co., Ltd.
M4-9-5, Economic & Technological Development Zone
Hangzhou 310018 CN
Other 510(k) Applications for this Company
Contact
Qing Liu
Other 510(k) Applications for this Contact
Regulation Number
870.1330
More FDA Info for this Regulation Number
Classification Product Code
MOF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/31/2022
Decision Date
06/29/2022
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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