Filmecc Co., Ltd. - FDA 510(k) Cleared Devices
Recent clearances: CROSSLEAD Standard 035 and CROSSLEAD Stiff 035, Vassallo GT 018 Hybrid, VASSALLO GT EXT
6
Total
6
Cleared
0
Denied
FDA 510(k) Regulatory Record - Filmecc Co., Ltd. Cardiovascular ✕
6 devices
Cleared
Sep 03, 2026
CROSSLEAD Standard 035 and CROSSLEAD Stiff 035
Cardiovascular
139d
Cleared
Mar 09, 2023
Vassallo GT 018 Hybrid
Cardiovascular
115d
Cleared
Oct 26, 2022
VASSALLO GT EXT
Cardiovascular
56d
Cleared
Jun 30, 2022
VASSALLO GT 018 Floppy
Cardiovascular
195d
Cleared
May 04, 2021
VASSALLO GT Hybrid
Cardiovascular
153d
Cleared
Apr 21, 2021
VASSALLO GT
Cardiovascular
140d