Medical Device Manufacturer · JP , Hagoya-Shi

Filmecc Co., Ltd. - FDA 510(k) Cleared Devices

5 submissions · 5 cleared · Since 2021
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Filmecc Co., Ltd. Cardiovascular ✕
5 devices
1-5 of 5
Cleared Mar 09, 2023
Vassallo GT 018 Hybrid
K223432 · DQX
Cardiovascular · 115d
Cleared Oct 26, 2022
VASSALLO GT EXT
K222631 · DQX
Cardiovascular · 56d
Cleared Jun 30, 2022
VASSALLO GT 018 Floppy
K213949 · DQX
Cardiovascular · 195d
Cleared May 04, 2021
VASSALLO GT Hybrid
K203529 · DQX
Cardiovascular · 153d
Cleared Apr 21, 2021
VASSALLO GT
K203533 · DQX
Cardiovascular · 140d
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