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FDA 510(k) Application Details - K203529
Device Classification Name
Wire, Guide, Catheter
More FDA Info for this Device
510(K) Number
K203529
Device Name
Wire, Guide, Catheter
Applicant
Filmecc Co., Ltd.
1703 Wakita-cho, Moriyama-ku
Nagoya 463-0024 JP
Other 510(k) Applications for this Company
Contact
Toshiya Osawa
Other 510(k) Applications for this Contact
Regulation Number
870.1330
More FDA Info for this Regulation Number
Classification Product Code
DQX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/02/2020
Decision Date
05/04/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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